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U.S. Department of Health and Human Services

Enforcement Report - Week of November 4, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Oma's Purr, Complete Feline Poultry Meal. Net Weight: 12 oz (340 g). and Net Weight: 2 lbs (907 g.). Product is sold in frozen in a plastic container. Code # 1524. UPC Codes: 12 oz. #879384000179 and 2 lb. #879384000186 Class I Product tested positive for Salmonella. Miller Foods Inc.
Devices ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer. model numbers: ONCOR Avant-garde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression - 07360717 ONCOR Impression - 05857920 PRIMUS HI - 04504200 MEVATRON M2/PRIMUS Mid-Energy  01940035 ARTISTE - 08139789 with serial numbers: 3986 3855 2958 3753 3751 70-4287 3781 5060 3203 3798 70-4316 3383 3832 3942 4067 5844 3953 5148 3802 70-4172 70-4143 70-4296 70-4235 70-4257 5474 70-4368 70-4363 3738 3817 3791 3793 5207 3458 3673 3241 3524 3574 3519 3225 3835 3367 3296 3591 3905 3922 3924 3773 3679 3533 3618 70-4356 5540 3103 5488 3859 4019 5821 3503 70-4344 3285 3979 3413 3774 3318 70-4183 3888 3361 5098 5385 3756 3305 3604 3629 3136 3788 70-4323 3666 3825 70-4207 4036 70-4166 3617 3736 3842 70-4188 5861 5222 3484 3302 3068 5656 5245 5092 3778 5088 3303 4021 3245 5665 3815 3133 3846 3907 70-4174 3534 5353 70-4185 3639 3274 3664 3801 3878 3949 2894 5572 3699 5417 4059 5500 5388 3547 3678 3186 70-4362 70-4379 3804 3623 3453 3602 3657 3948 70-4135 3755 5033 3622 3731 2855 4065 4091 3644 4018 70-4306 3114 3565 3711 4015 3981 3998 3975 5093 5008 3939 5095 3901 5153 3244 5154 Class II potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option. Siemens Medical Solutions USA, Inc
Veterinary Virbac Animal Health, KetoChlor Shampoo Medicated Shampoo for dogs, cats, and horses, Chlorhexidine Gluconate 2.3% w/w, Ketoconazole 1% w/w; Packaged in 8 oz bottles, NDC 51311-028-08. The responsible name on the bottle is Virbac Animal Health, Fort Worth, TX 76161. 140434, Exp 04/2016 Class II Some of the products may be missing labels. Virbac AH, Inc
Veterinary Virbac UROEZE 400, each 0.65 g (1/4 level teaspoon) contains 400 mg ammonium chloride, packaged in 4 oz bottles, NDC 051311-850-04. Mfg. by Virbac, AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 131106, Exp 09/2015 Class II Some of the products may be missing labels. Virbac AH, Inc
Veterinary Virbac Virbantel (pyrantel pamoate/praziquantel) Flavored Chewables packaged 50 flavored chewable per bottle, 114 mg pyrantel pamoate and 114 mg praziquantel. De-wormer for Dogs Only Medium and Large dogs - 25.1 to 200 lbs. NADA 141-261, NDC 051311-741-50, Mfd. by: Virbac AH, Inc., Fort Worth, TX 140756, Exp 04/2017 Class II Some of the products may be missing labels. Virbac AH, Inc
Veterinary Excenel RTU EZ - Ceftiofur Hydrochloride Sterile Suspension; 100 mL container - glass vial 50 mg/mL; NADA 141-288 - WHOCC ATC Vet code ; QJ01DD90 Product Code 10002487 Zoetis LLC. lot 4F0757, expiry 6/30/2015. Class III Expired Excenel TRU EZ Sterile Suspension (6/2015) was shipped to seven customers in July 2015.. Zoetis Inc
Drugs ALPROSTADIL, Injectable Solution, 40 MCG/ML, 10 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06152015@29 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ALPROSTADIL/PROCAINE, Injectable Solution, 20 MCG/0.1%/ML, 10 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 01122015@4, 02022015@2, 02102015@29, 02202015@14, 03302015@9, 04132015@7, 04222015@4, 05062015@6, 05132015@2, 05272015@11, 06032015@1, 06102015@6, 06222015@9, 06232014@2, 07082015@4, 07112014@22, 07292014@33, 08182014@8, 09022014@5, 09092014@27, 09172014@3, 10082014@3, 10272014@2, 11052014@2, 11262014@4, t03062015@44, t03242015@26, t06242015@8, t07182014@23, t11102014@21, and t12292014@19. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t01212015@26, t01292015@12, t02062015@28, t02092015@14, t02182015@37, t03112015@21, t03302015@3, t05182015@26, t06012015@9, t06042015@31, t06102015@29, t06222015@36, t07062015@4, t07312014@30, t08052014@19, t10082014@18, t10132014@8, t10142014@11, t10232014@23, t11072014@7, t11112014@24, t11182014@13, t12152014@15, and t12162014@7. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs B1/B2/B3/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/50/5/1/10/25/8/17/17 MG/ML, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05122015@3 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/5/1/10/25/8/17/17 MG/ML, 30 mM vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05212015@13, t06032015@22, t06102015@17, t06292015@19 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06112015@21, t06172015@43, t07062015@30 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN, Injectable Solution, 4000 UNITS/ mL, 8 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05062015@33, t08212014@16, t02032015@14 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12172014@5, t12162014@23, t09102014@8, t05272015@14, t05222015@20, t03202015@23, t03062015@32, and t02122015@14. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with Methylcobalamin, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 04292015@12, 05042015@8, 05202015@21, 06102015@25, 06242015@14, 07012015@8, 07062015@21, t03062015@15, t03122015@33, t03182015@45, t03192015@2, t04082015@14, t04082015@3, t04202015@22, t05082015@27, t05192015@29, t06022015@37, and t07152015@5. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 11032014@10, 12082014@3, t01082015@26, t03092015@26, t03132015@13, t03162015@12, t03242015@19, t04092015@21, t05132015@28, t05132015@44, t05202015@22, t05262015@14, t05272015@36, t06172015@27, t06182015@7, t06242015@9, t06292015@11, t07092015@42, t07102015@25, t08012014@1, t09122014@19, t09252014@4, t12242014@2, and t12312014@8. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12292014@35, t12192014@15, t12162014@29, t10232014@24, t09162014@29, t09032014@6, t07252014@16, t07142015@6, t07022015@8, t06152015@32, t05272015@33, t04282015@11, t04162015@34, t04092015@8, t04022015@30, t02262015@24, t02032015@21, and t01232015@10 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 150 UNITS/0.150 ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07012015@9 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 175 UNITS/0.175ML per syringe, packaged in 14, 26, and 40-count containers, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 01052015@18, 01072015@12, 01122015@13, 01142015@7, 01192015@18, 01212015@16, 01262015@11, 02022015@13, 02192015@10, 02232015@22, 03042015@20, 03092015@46, 03162015@13, 03182015@17, 03252015@23, 03302015@13, 04012015@11, 04152015@14, 04212015@15, 04272015@13, 05062015@19, 05112015@27, 05202015@16, 05272015@29, 06032015@19, 06102015@27, 06152015@31, 06172015@40, 06222015@27, 06292015@27, 07012015@12, 07062015@16, 07092014@4, 07152015@13, 07162014@3, 07212014@4, 07232014@15, 07282014@14, 07302014@5, 08112014@19, 08182014@7, 08252014@14, 09022014@22, 09152014@10, 09172014@16, 09222014@6, 09292014@22, 10062014@15, 10132014@20, 10222014@14,  ...
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Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t01292015@25, t04132015@3, t04232015@27, t05132015@22, t06232015@26, t08052014@6, t11042014@11. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 250 UNITS/0.25ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t04292015@13 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03272015@13 and t04292015@14 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 1000 units/1 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05112015@18, t05222015@21, t06092015@1 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05192015@19 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t01062015@24 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs DEXPANTHENOL, Injectable Solution, 250 MG/ML, 30 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05282015@25 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t02162015@9, t04132015@10, t05192015@15, t07062015@20, t07242014@11, t08292014@13, t11212014@17, t12312014@15. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL, 5mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07012015@25 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07012015@24 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 12.5 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03132015@20, t07072015@13 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 07102015@10 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07312014@14 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 20 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12022014@19, t08132014@24, t08042014@40, t07082015@25, t06192015@25, t03192015@5, t02162015@11, t02062015@12. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03132015@5, t05182015@21 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10222014@3, t10202014@24, t09022014@12, t08082014@20, t07222014@33, t06112015@38, t04232015@28, t04072015@12, t02182015@7, t01122015@14. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 30 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06162015@18 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12092014@19, t11252014@18, t09222014@34, t09082014@23, t09052014@11, t08262014@16, t08042014@36, t07022015@34, t06022015@28, t05112015@13, t03302015@22, t03062015@27, t01232015@23, t01022015@16, 10242014@3, 10072014@5. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12242014@13, t12092014@20, t11172014@26, t10032014@20, t09162014@19, t08152014@8, t07232014@21, t06122015@14, t05222015@11, t04092015@5, t02252015@11, t01122015@34. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t11122014@22, t10282014@8, t05122015@2, t02022015@17, t01282014@25. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ESTRADIOL, Pellet, 9 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12052014@17, t11192014@17, t11072014@13, t07202015@15, t05142015@15, t03052015@3. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs ETHYL ALCOHOL (STERILE FOR INJECTION) 100%, Injectable Solution, 200 PROOF, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05192015@11 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs FOLIC ACID (COMPOUNDED), Injectable Solution, 5 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06032015@23 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs FOLIC ACID, Injectable Solution, 10 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t02182015@36, t03052015@23, t03302015@17, t05132015@33, t06192015@20, Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12012014@6, t09182014@28, t09162014@31, t09162014@22, t08292014@6, t08122014@26, t07222014@15, t05262015@13, t01192015@11, t05082015@4, t04202015@13 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL syringe , Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03192015@31, t04272015@5 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t02052015@24 and t04282015@22. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 1.5 mg/0.25 mL, 20 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12192014@13, t11212014@24, t10022014@24, t09092014@17, t06112015@34, t05182015@12, t03062015@39, t03032015@22, t02202015@18, t01292015@26, t01192015@10. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03312015@20, t05062015@28, t06082015@22, t05112015@17. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10032014@12, t11032014@18, t02022015@4 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes: 6 mL, 10 mL, 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12232014@26, t10302014@14, t09232014@18, t09052014@20, t08132014@15, t07222014@23, t06302015@24, t03192015@37. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5 mg/0.25 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07092015@35 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12182014@7, t12052014@12, t10312014@21, t10102014@21, t10072014@6, t09172014@30, t09152014@11, t08132014@13, t08112014@28, t07282014@28, t07282014@16, t07012015@7, t06302015@31, t06222015@17, t06112015@14, t06022015@17, t05182015@24, t05152015@19, t05072015@9, t04272015@19, t04232015@22, t04212015@16, t04162015@21, t04092015@2, t04022015@27, t03162015@16, t03052015@25, t03022015@13, t02272015@22, t02202015@23, t02172015@8, t02132015@19, 08202014@12, 05042015@11; t02062015@29, t03312015@5, t06052015@3, t06172015@47, t06292015@13, and t10232014@22, t07242014@6 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03182015@4 and t07062015@5 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03192015@20, t06012015@6, t04292015@18, t06192015@16, t07012015@26 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN, injectable Solution, 10 MG/ML, syringe sizes: 10mL; 22.5mL; and 30mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t08062014@8, t05152015@25, t01192015@26, t01072015@7. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12312014@6, t12042014@26, t11252014@31, t10302014@35, t10282014@27, t10242014@14, t10032014@26, t10012014@18, t09302014@13, t09222014@22, t09172014@24, t09052014@1, t08132014@16, t07302014@2, t07222014@21, t06302015@5, t06182015@4, t04102015@10, t04062015@2, t03062015@8, t03032015@1, t02102015@22, t01272015@19, t01052015@31, 03312015@14 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12232014@10, t12052014@10, t11182014@16, t11182014@1, t10202014@5, t10132014@2, t09292014@7, t07082015@6, t07082015@30, t06112015@31, t06092015@34, t06052015@27, t06022015@9, t05282015@22, t05262015@8, t05202015@31, t04272015@11, t04132015@19, t03182015@46, t03172015@15, t03052015@22, t01192015@5. t06242015@31, t04022015@16, t02182015@34, t04172015@25, t05132015@30, t06192015@17 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN MDV, Injectable Solution, 2 MG/ML, 10mL syringe; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06042015@22, t01202015@4, t05082015@5 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN MDV, Injectable Solution, 5 MG/ML, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05282015@23 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size: 12 mL, 20 mL, 30 mL, 40 mL, 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 01022015@27, 01212015@13, 02042015@2, 02182015@3, 03042015@3, 03092015@12, 03182015@19, 03252015@7, 04152015@3, 04292015@4, 05112015@2, 05132015@10, 05262015@1, 06032015@6, 06082015@6, 06152015@5, 06242015@3, 06292015@9, 07092014@1, 07292014@35, 08062014@3, 08272014@1, 09292014@12, 10202014@11, 11052014@5, 11262014@7, 12082014@11, 12292014@5, t04032015@17. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t07142015@46 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES, Injectable Solution, 2.5/0. 5MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t09232014@24, t03122015@11 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t09172014@29, t08252014@1, t06082015@10, t03032015@26, t02272015@23, t01232015@12, t01122015@36, t05132015@15 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0. 1MG/10MCG/ML, syringe 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05222015@6 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 30 MG/2 MG/0. 1MG/20MCG, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03312015@8 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/10 MCG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10282014@28, t02272015@9 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 06152015@9, t04022015@17. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12292014@29, t11262014@15, t11202014@25, t11202014@10, t08292014@26, t07072015@20, t06222015@10, t06162015@16, t06012015@10, t05292014@20, t04302015@13, t04162015@8, t03102015@3, t02062015@13, t01062015@20. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t08042014@18, t07082015@26, t07072015@12, t03132015@6, t02162015@12. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10292014@22, t09022014@13, t08262014@11, t06192015@24, t05072014@11. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs PYRIDOXINE HCL, injectable Solution, 100 mg/mL, 30mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05292015@5 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 4.5/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314. t04162015@33, t05112015@19, t05282015@2, t07062015@7, t07092015@43. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10062014@19, t09152014@13, t08262014@1, t08072014@20, t05282015@28, t03062015@14, t02162015@26, 12222014@3, 11262014@6, 11172014@4, 11052014@3, 10272014@7, 10222014@23, 10202014@20, 10152014@5, 10012014@17, 09102014@3, 08182014@9, 07222014@31, 06292015@10, 06232014@3, 06222015@6, 05132015@7, 05062015@7, 05042015@4, 04272015@8, 04222015@6, 03302015@11, 03252015@9, 02202015@24, 01232015@20, 01192015@1, 01052015@8. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12052014@8, t11192014@26, t11032014@24, t10142014@27, t09172014@2, t08252014@30, t07302014@12, t07092014@15, t06022015@10, t04302015@22, t03312015@18, t03172015@28, t03092015@38, t02102015@21, 10222014@8, 10012014@16, 05132015@5, 02172015@7, 01052015@9. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 06152015@10 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 01202015@19, 05192015@3, 07222014@27, 08192014@4, 09042014@5, 09232014@21, 10032014@24, 10092014@12, 12012014@16, t01152015@6, t02232015@23, t03122015@1, t03202015@10, t04232015@11, t05062015@22, t05182015@29, t06012015@12, t06112015@10, t06132014@15, t08112014@30, t12182014@19. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12152014@14, t12012014@1, t11202014@24, t10032014@18, t09292014@8, t09192014@15, t09162014@8, t07132015@13, t06122015@2, t05262015@11, t05232014@5, t04092015@14, t03062015@26, t03042015@17, t02272015@21, t02182015@31, t02092015@24, t01162015@14, t01022015@15, 11192014@8. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 106 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12082014@45, t05122015@7, t04012015@13, t03062015@7. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 110 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12292014@16, t12022014@29, t11262014@23, t11122014@9, t09262014@9, t09232014@26, t08222014@21, t08152014@7, t07022015@35, t06192014@7, t06102015@12, t05012015@28, t04162015@31, t03052015@2, t02132015@22, t01152015@7. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12192014@18, t12092014@37, t11252014@6, t11192014@25, t10212014@24, t10172014@18, t09252014@14, t07162015@28, t07152014@12, t07062015@13, t06042015@18, t05282015@27, t04242015@23, t03192015@35, t02242015@23, t02192015@15, t02062015@9, t01292015@27, 11052014@20, 04102015@9. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 115 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06022015@27, t05272015@37, t05222015@16, t03232015@16, t03062015@36, t01132015@8, t01082015@15. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 116 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t04092015@12 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12052014@18, t11252014@19, t11192014@18, t11112014@4, t09192014@18, t09102014@20, t08272014@10, t06242015@30, t06022015@8, t05202015@11, t05042015@22, t05012015@17, t04102015@4, t03302015@21, t03202015@18, t03052015@12, t02252015@10, t01302015@23, t01232015@24, t01142015@21. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 125 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 01052015@21, 01162015@21, 02122015@8, 03252015@14, 04022015@14, 04102015@8, 04172015@30, 05192015@8, 06162014@12, 07102015@6, 07222014@18, 08072014@3, 08192014@5, 09022014@36, 09102014@26, 09192014@19, 10032014@25, 10092014@11, 10282014@1, 10312014@8, 11122014@27, 12032014@13, t03042015@9, t06022015@13, t06272014@20. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t06052015@16 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12222014@29, t11122014@23, t10282014@9, t09192014@14, t08082014@3, t03052015@6. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 50 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12292014@30, t11202014@11, t10132014@24, t09042014@30, t08252014@23, t06292015@23, t06252015@16, t06052015@8, t05162014@7, t05072015@11, t04302015@14, t03102015@5, t03052015@8, t03032015@33, t02182015@29, t01092015@2. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 60 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12082014@41, t09152014@40, t08062014@5, t02112015@16. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 70 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t01022015@4, t02102015@23, t03242015@18, t05012015@14, t09052014@10, t09182014@17. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 76 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12172014@7, t12092014@16, t10062014@26, t08252014@4, t05292015@3, t05212015@18, t05052014@11, t04012015@1, t01202015@15, t01052015@30. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 80 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10222014@22, t10032014@21, t09092014@15, t09032014@11, t06292015@18, t06022015@6, t02132015@16, t02122015@1, t01092015@5. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE, Pellet, 90 mg, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 03302015@26, 10092014@13, t02272015@8, t03182015@50, t03192015@32, t06162015@24, t07012015@4, t07022015@29, t08012014@17, t08012014@6, t08042014@37, t09032014@10, t12052014@24, t12242014@4. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12232014@27, t11112014@12, t08072014@38, t07142015@22, t07102015@26, t06232014@25, t06042015@24, 06172015@13, 04202015@7, 03092015@11, 02022015@3, 01192015@8, 01052015@10. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 100 mg/mL, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12102014@3, t06252015@37 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 5ml and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12312014@11, t10302014@9, t08062014@28, t05292015@30, t04282015@12, t04092015@22, t03302015@1, t03102015@29, t02172015@2, t01292015@18, 12082014@10, 11242014@5, 11122014@5, 10222014@24, 10012014@19, 09242014@7, 09152014@17, 08152014@27, 08042014@6, 07112014@23, 07082015@8, 06172015@14, 05272015@12, 05132015@12, 04082015@1, 03092015@11, 02232015@2. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE PROPRIONATE, Injectable Solution, 100 mg/mL, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t02102015@6, t03162015@29, t04142015@12, t05132015@11. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t05132014@15, t08262014@18, t11112014@21. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t09262014@23, t07282014@9, t07012014@11, t06092015@8, t05132015@6, t02172015@13, t01232015@7, 07222015@1. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12192014@8, t12122014@20, t11212014@2, t10232014@25, t09292014@4, t09162014@13, t08082014@19, t06082015@2, t05042015@2, t04082015@21, t04022015@24, t03232015@5, t02092015@25, t01222015@9. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t11242014@14, t10082014@1, t08152014@22, t08042014@31, t07252014@19, t07142015@19, t07102015@24, t07082014@2, t04142015@25, t04062015@16, t02242015@29, 12152014@9, 12032014@4, 11122014@2, 10292014@3, 10012014@15, 09232014@23, 09032014@3, 08132014@1, 06242015@4, 06172015@12, 06102015@5, 05272015@10, 05182015@6, 05132015@9, 05042015@5, 04222015@8, 03112015@4, 02102015@30, 01232015@6, 01072015@5; Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12082014@33, t12012014@10, t11072014@5, t10202014@19, t08282014@10, t07282014@29, t01222015@18, t02122015@33 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12012014@40, t11042014@10, t10012014@40, t08122014@27, t03092015@44, t01082015@24. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t12102014@2, t11212014@14, t11102014@22, t11072014@10, t10102014@20, t08072014@37, t06222015@13, t06192015@27, t06112015@23, t04142015@9, t02272015@26. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs TRIMIX, injectable Solution, 40MG/2MG/40MCG/ML, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t02272015@24, t04272015@22, t06022015@4. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs VITAMIN B-COMPLEX, Injectable Solution, Syringe size: 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t04172015@20 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t03032015@1, 04062015@1, 06292015@7, t04092015@10 Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Drugs VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx only,JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 t10242014@16, t05282015@21, t03182015@35. Class II Lack of Assurance of Sterility; all sterile human compounded drugs within expiry JD & SN Inc., dba Moses Lake Professional Pharmacy
Devices Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. Software Version 1.6 Class II It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect. Perkin Elmer Life Sciences Inc
Devices Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. 23076, 25396, 26210, and 27186 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery. 19215, 19570, 20849, 22557, 23871, 25469, and 27185 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. 24641 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. 22404, 23406, 23642, and 24032 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery. 19532, 27389, 24399, and 24478 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery. 26550 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery. 19345 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Devices Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery. 24634 Class II Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. Resource Optimization & Innovation Llc
Food Goya Mojo Criollo Marinade for Chicken, Pork & Beef (a) 12 ounce (b) 24.5 oz and (c) 1 Gallon containers; Goya Foods, Inc., Secaucus, NJ 07096 USA Distributor. Product of Dominican Republic 12 fl oz - UPC 0 4133103059 5; Best By Dates: JAN 2  ...
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Class II Goya was notified by one of its ingredient suppliers that one lot of cumin had potentially been produced with undeclared peanut protein. Goya Foods
Food Kirby Spanish Barbecue Sauce Mojo Criollo (a) 24 ounce and (c) 1 Gallon; Packed For Kirby Foods, Inc. Miami, Florida 33172; Product of Dominican Republic 24 ounce - UPC 0 7738518920 4; Best By Dates AUG 2016, SEP 2016, DEC 2016 1 Gallon - UPC 0 7738512346 4; Best By Date NOV 2016 Class II Goya was notified by one of its ingredient suppliers that one lot of cumin had potentially been produced with undeclared peanut protein. Goya Foods
Food Sincerely Nuts brand Macadamia Nuts (Raw) (a) Whole, sold in 1 lb., 2 lb. and 5 lb. packages; (b) Unsalted Halves and Pieces sold in 2 lb. packages --- The product is packed in sealed flexible plastic packages and do not have UPC codes. (a) Lot Number T7R1A22045, EXPIRES: 1/2016; (b) EXPIRES: 11/2015 (no lot code) Class I Raw Macadamia Nuts were found to be contaminated with Salmonella based on private laboratory testing. Sincerely Nuts
Veterinary VetBioTek BioCalm Spray - Lidocaine Hydrochloride 2.4% Soothing Spray for Relief of Hot Spots 2.0 oz P-1276 and 1281 Class II OOS - 2-month stability testing revealed microbial and yeast growth Vetbiotek Inc
Devices ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. All serial numbers Class II ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples. Siemens Healthcare Diagnostics, Inc.
Devices CIOS ALPHA; image intensified fluoroscopic x-ray system model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064 Class II patient procedure interruption due to a potential system failure Siemens Medical Solutions USA, Inc
Devices ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology. ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586,  ...
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Class II Incorrect tubing. Abbott Laboratories, Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W117015005932J Class II Blood products, which were collected from a donor who traveled in a malarial endemic area, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W117015005932J Class II Blood products, which were collected from a donor who traveled in a malarial endemic area, were distributed. Blood Centers of the Pacific - Irwin Center
Drugs Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01 Lot # C111054; Exp. 02/16 Class II Subpotent Drug Pfizer Inc.
Food Hellmann's Zesty Italian Dressing, One Gallon (128 fl oz) 3.70 L Lot CL2235 Best By 16JN05 Class I The firm manufactured salad dressing using romano cheese that they later learned was being recalled because it tested positive for Listeria monocytogenes MCF Operating LLC
Devices Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician. PCBAs PN #: 670-1670-00. SERIAL NUMBERS in the US: CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, and CARD-625421. SERIAL NUMBERS OUTSIDE THE US: CARD-000019, CARD-000028, CARD-000037, CARD-000046, CARD-000064, CARD-000073, CARD-000073, CARD-000082, CARD-000091, CARD-000109, CARD-000118, CARD-000127, CARD-000136, CARD-000145, CARD-000163, CARD-000172, CARD-000181, CARD-000190, CARD-000208,  ...
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Class II When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally. Spacelabs Healthcare Inc
Devices Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella. 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008 Class II The labeling is missing the size/diameter information. Encore Medical, Lp
Biologics Platelets Pheresis Leukocytes Reduced W115115214489B Class II Blood product, with a low platelet yield, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Devices Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78810, 78812, 78814 and 78816, Rx ONLY all lots Class II The firm became aware that the KleenSpec® 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard. Welch Allyn Inc
Devices Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems. Lot # 52748L02A Class II During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. Encore Medical, Lp
Devices Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems. Lot # 52748L02A Class II During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. Encore Medical, Lp
Biologics Platelets Pheresis Leukocytes Reduced W044215360042 (double) Class II Plateletpheresis products, collected without the required QC being performed, were distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W069109152220 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069109152220 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W20131581248000 Class II Blood product, which was not tested for pH and platelet yield, was distributed. American National Red Cross
Food Breaded Ravioli 10 lb. Mfg Foods R Us Scottsdale, AZ 85260 480-951-1883 Product is coded with pack dates. All pack dates are included. Class I Foods R US is recalling Breaded Ravioli due to undeclared soy, milk, and wheat. Foods R US
Biologics Red Blood Cells Leukocytes Reduced W223215569731 Class III Blood products, collected from a donor who did not have a satisfactory arm inspection, were distributed. United States Blood Bank, Inc.
Biologics Blood and Blood Products for Reprocessing W223215569731 Class III Blood products, collected from a donor who did not have a satisfactory arm inspection, were distributed. United States Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced W223215570755 Class III Blood products, collected from a donor who did not have a satisfactory arm inspection, were distributed. United States Blood Bank, Inc.
Biologics Blood and Blood Products for Reprocessing W223215570755 Class III Blood products, collected from a donor who did not have a satisfactory arm inspection, were distributed. United States Blood Bank, Inc.
Food Kermit's Key Lime Cocktail Sauce, 12 oz, Key West, FL, UPC 007172006076 & 0802468905503 Best by date of 09/01/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Key Lime Steak Sauce, 10 oz, Key West, FL, UPC 231920085093 Best by date of 08/18/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Sweet & Tasty Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 011550150134 & 802468905411 Best by date of 09/14/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Medium Mannered Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501409 Best by date of 08/11/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Hot & Spicy Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501423 & 802468905312 Best by date of 08/19/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Chipotle Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 091920850929 Best by date of 07/24/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's P4 Hot Sauce, 5.5 oz, Key West, FL, UPC020108012019 & 802468905701 Best by date of 08/20/2016 or before Class II Undeclared soy on product label Kermit, Inc.
Food Kermit's Key Lime Ginger Wasabi Marinade, 12 oz, Key West, FL, UPC 070820060706 & 802468905480 Best by date of 08/31/2016 or before Class II Undeclared soy and wheat on product label Kermit, Inc.
Devices Integra® Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box. There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253 Class II Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial. Integra LifeSciences Corp. d.b.a. Integra Pain Management
Biologics Source Plasma LC0848602, LC0850839 Class II Blood products, which were not quarantined after receiving post donation information concerning receipt of a tattoo, were distributed. BPL Plasma, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036815243159 (double) Class II Blood products for which some quality control procedures were not performed, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W036815300327; W036815243585 Class II Blood products for which some quality control procedures were not performed, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W036815292293 (double); W036815255279 (double); W036815121241 (double); W036815273639 (triple); W036815276096 (quadruple); W036815300327 Class II Blood products for which some quality control procedures were not performed, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036514174427 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. LifeShare Blood Centers
Devices Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070,  ...
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Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359,  ...
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Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022, 52025, 52027, 52029, 310116, 310150, 310152, 310153, 310154, 310155, 310156, 310158, 310161, 310162, 310163, 310164, 310166, 310171, 333013, 333026, 333027, 333028, 333032, 333035, 333036, 333037, 333038, 333039 &333042. Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141,  ...
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Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128, 7158, 7170, 7173, 7178, 7193, 7204, 7214, 7221, 7228, 7231, 7235, 7246, 7262, 7265, 7273, 7284, 7328, 7347, 7353, 7364, 7365, 7370, 7395, 7400, 7403, 7434, 7435, 7462, 7467, 7481,  ...
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Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046,  ...
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Class II The firm discovered Ring/Dot artifact due to X-ray measurement error. Philips Medical Systems (Cleveland) Inc
Devices CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint® Blood Analysis System. ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI Class II May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood. LifeHealth, LLC
Devices BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint® Blood Analysis System. EOSCU EOTUZ EOVMW EOYUL EPANW EPCED EPDVM EPFOJ EPIXX EPKOJ EPNXA Class II May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood. LifeHealth, LLC
Devices Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Lot 50083Y600, expiration date 31 Jul 2016. Class II Results for ammonia below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes Sentinel CH SpA
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W203415828092; W203415828099 (triple); W203415828075 (triple); W203415828092 (double) Class II Blood products, that did not meet QC specifications, were distributed. American Red Cross Blood Services Northern NewEngland Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W071215018561 (double) Class II Blood products, for which the quality control testing for residual white blood cell count was not performed, were distributed. Medic Inc
Food Moonstruck Chocolates 9 piece Nuts & Chews Collection. The box contains 9 different nut and chews, various shapes, in 9 different flavors. Net Wt. 5.19oz (147g). Item Number: 310896, UPC: 7 11175 10896 4. Best Enjoyed by: Jan 4 2016 and Jan 18 2016 Class II Moonstruck Chocolates 9pc Nuts & Chews Collection product is recalled due to undeclared sulfite. Moonstruck Chocolate Company
Devices BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic. Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017) Class III Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Becton, Dickinson and Company, BD Biosciences
Food Sunkist Frozen Mango Fruit Sorbet Bar 6 x 2.5 FL OZ. (74 mL) Bars/ 15 FL OZ (444 mL) and pint (473 mL) UPC: 51819-00303 Plant Code: 18-1681 Class I Undeclared milk Dean Foods, Inc.
Devices 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Part Number 202.212 Lot Number 3420620 Class II Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. Synthes (USA) Products LLC
Food Snack Out Loud Sea Salt Crunchy Bean Snacks 1.2 OZ Single Serve Units. lot #63361, UPC #760055900037 Class I Fresca Foods conducted a recall on Snack Out Loud Sea Salt flavored Crunchy Bean Snacks due to ranch flavored product being packaged in the sea salt bags, which contain undeclared milk. Fresca Foods, Incorporated
Food Trader Joes Coconut Cranberry Granola (SKU 51131), packaged in a 16 oz. box, with Best By date 08/19/16 printed at the top of the package UPC Code: 0051 1315 printed on side panel. Best By Date: 08/19/16 Class I Pecan Praline granola was packed into Coconut Granola boxes. Product may contain undeclared milk, wheat, and pecans. New England Natural Bakers, Inc.
Devices Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device. Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613 Class II The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate. Synthes (USA) Products LLC
Devices Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Lot # 15C03 Class II Some 1 1/4" needles that were packaged and labeled in the 1" blister package. Nipro Medical Corporation
Food American Pure Whey, Whey Protein Matrix Chocolate flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC. Lot number: 69205, UPC Code 456456789004 Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Food American Pure Whey, Whey Protein Isolate (Chocolate flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC. Lot number: 29026, UPC Code 753182812809 (chocolate) Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Food Body Construct, Meal Replacement, Cinnamon Roll flavor, 2lb, Distributed by Body Construct. Lot number: 78124, Exp. Date: 9/2017, UPC Code: 839893989858 Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Food Build Your Own Body, Protein Powder, Manufactured for Build Your Own Body, Flagstaff Arizona. Lot number: 67134, Exp. Date: 9/2017, UPC Code: 456789517480. Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Food American Pure Whey, Whey Protein Matrix Vanilla flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC. Lot number: 69205, UPC Code, 783521095013 Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Food American Pure Whey, Whey Protein Isolate (Vanilla flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC. Lot number: 29026, UPC Code 78333109591 Class I Undeclared Allergens; Soy and Milk. American Pure Whey
Devices ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes. Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 402562 402566 400063 400066 400090 400261  ...
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Class II Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected. Siemens Medical Solutions USA, Inc.
Devices ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes. Serial Numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401366 401370 401406 401460 401591 401750 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 402562 402566 400063 400066 400090 400261 400350 400763 400787 400789 400790 400791 400792 400794 400797 400881 400886 400888 400890 400892 400898 401957 402451 400139 400141 400171 400235 400287 400291 400292 400293 400337 400338 400351 400458 400459 400475 400526 400527 400529 400583 400589 400593 400620 400693 400720 400743 400843 400868 400872 400873 400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401041 401044 401065 401075 401081 401083 401130 401132 401175 401187 401237 401243 401271 401286 401291 401305 401426 401441 401445 401540 401590 401662 401705 401725 401728 401744 401746 401753 401758 401810 401832 401841 401863 401889 401892 401910 401915 401916 401917 401929 401943 401969 402011 402027 402050 402051 402077 402109 402131 402190 402191 402220 402226 402229 402242 402243 402244 402253 402257 402260 402275 402296 402341 402379 402396 402398 402436 402443 402444 402503 402514 402570 402579 400065 400100 400492 400715 400914 401108 401109 401255 401638 401641 401845 402279 400174 400440 400448 400538 400541 400572 400615 400622 400623 400626 400799 400830 400882 400931 401049 401115 401285 401343 401375 401397 401402 401409 401424 401425 401430 401570 401730 401734 401991 402026 401890 401898 401899 401906 400029 400070 400195 400223 400224 400233 400309 400454 400456 400530 400552 400617 400814 400818 400835 401281 401476 401547 401565 401567 401568 401602 401900 401950 401959 401961 402280 402322 402449 400472 401173 401289 401501 401507 401552 401600 401797 401825 401837 402236 402386 400665 400676 400678 400683 400822 400145 400179 400310 400311 400968 401378 401446 400175 400226 400236 400244 400245 400264 400267 400269 400283 400288 400297 400536 400629 400640 400679 400680 400717 400757 400759 400768 400773 400775 400788 400795 400800 400832 400848 400874 400883 400884 400885 400905 400967 400974 401028 401111 401258 401265 401266 401278 401348 401379 401384 401386 401391 401423 401429 401491 401494 401572 401584 401592 401610 401621 401636 401639 401674 401678 401732 401737 401747 401862 401864 401867 401872 401918 401987 402025 402028 402081 402118 402200 402215 402216 402320 402407 402448 402481 400220 400221 400435 400437 400451 400767 400803 400821 400862 400986 401177 401453 401462 401574 401575 401765 402406 402442 402489 401040 400570 401007 401010 401020 401235 401252 401520 401564 401611 401804 401846 402030 402336 402454 402476 402500 402511 402513 401691 401771 402143 402271 402273 402290 402306 402325 400442 400486 400487 400489 400564 400998 400999 401979 402029 400449 401562 401597 401648 402094 400048 400093 400118 400132 400143 400295 400431 401216 400023 400069 400088 400120 400126 400265 400299 400326 400480 400485 400550 400689 400691 400700 400742 400786 400893 400913 400979 401112 401315 401351 401373 401461 401625 401631 402023 402031 402048 402258 402313 402319 402332 402357 402391 402431 402484 400123 400137 400152 400197 400234 400312 400436 400477 400669 400817 400929 400972 401054 401055 401067 401071 401503 401836 402010 402018 402022 402056 402125 402127 402145 402168 402214 402222 402228 402230 402254 402318 402333 402337 402354 402377 Class II Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected. Siemens Medical Solutions USA, Inc.
Devices ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories, including dose delivered to defined sites, and provides tools to verify performed treatments. Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license. Class II An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. Varian Medical Systems, Inc.
Food Sobisk Lemon Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 1/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs. BEST BY 1/31/2017 Class II Lemon Cream Cookies imported from India, contain undeclared color - FD & C Yellow #5. Sobisk Foods LLC
Food Sobisk Orange Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 03/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs. BEST BY 03/31/2017 Class II Orange Cream Cookies, imported from India, contain undeclared colors including FD & C Red #3, Yellow #5, #6. Sobisk Foods LLC
Food Sobisk Strawberry Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 01/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs. BEST BY 1/31/2017 Class II Strawberry Cream Cookies, imported from India, contain undeclared colors including FD & C Red #3 and Yellow #6. Sobisk Foods LLC
Biologics Apheresis Platelets, Leukocytes Reduced W221615503976 (2 units) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. Central Texas Regional Blood & Tissue Center
Drugs PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 Lot#: 09082015@36, Exp 10/8/15 Class II Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy
Drugs METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 Lot#: 09102015@6, Exp 3/8/16 Class II Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy
Drugs TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 Lot# 09152015@8, Exp, 10/15/15 Class II Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy
Drugs CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 Lot# 08062015@27, Exp, 11/4/15 Class II Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy
Drugs TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 Lot# 09162015@4, Exp, 10/16/15 Class II Lack of Assurance of Sterility: all sterile compounded products within expiry Chen Shwezin, Inc. dba Park Compounding Pharmacy
Devices Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. Software Version 5.10.01 Class II Unintended update of Dose and MU and Incorrect Assignment of Bolus. Elekta, Inc.
Devices Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System. 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03 Class II Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. Materialise N.V.
Biologics Skin 06514053761035; 06514053761036 Class II Human skin allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Musculoskeletal Transplant Foundation, Inc.
Food Red Velvet Bundt Cake n/a Class II My Dad's Favorite Cookies is recalling red velvet bundt cakes, red velvet cupcakes and all cupcakes with colored frosting and/or colored sprinkles of undeclared FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6 colors. My Dads Favorite Cookies, LLC
Food Assorted Mini Cupcakes, 12 pack and 4 pack n/a Class II My Dad's Favorite Cookies is recalling red velvet bundt cakes, red velvet cupcakes and all cupcakes with colored frosting and/or colored sprinkles of undeclared FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6 colors. My Dads Favorite Cookies, LLC
Food Assorted Large Cupcakes, 2 pack and 1 pack n/a Class II My Dad's Favorite Cookies is recalling red velvet bundt cakes, red velvet cupcakes and all cupcakes with colored frosting and/or colored sprinkles of undeclared FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6 colors. My Dads Favorite Cookies, LLC
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