• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells 01E91917 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 4565963A; 4565963B; 4565953A; 4565953B Class III Blood products, which were labeled with an incorrect volume, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced. 4092092 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, was distributed. Northwest Florida Blood Center, Inc.
Biologics Fresh Frozen Plasma 5212449 Class II Blood products, which quality control and distribution/required testing not performed were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 5212449 Class II Blood products, which quality control and distribution/required testing not performed were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 8604369 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Florida Georgia Blood Alliance, Inc.
Biologics Platelets Pheresis Leukocytes Reduced FE18334,PART1; FE18334,PART2 Class II Blood products, which were collected from a donor who had taken aspirin prior to the donation, were distributed. Children's Hospital of Orange County: Blood & Donor Services
Biologics Platelets Pheresis Leukocytes Reduced 71X077426 Class III Blood product, for which the quality control testing was incomplete, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Source Plasma FT01233251; FT01233373; FT01233495; FT01233601 Class II Blood products, which tested negative for the human immunodeficiency virus (HIV) but were collected from a donor who previously tested positive for HIV, were distributed. Life Sera, Inc.
Biologics Platelets 4050499 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 4050499 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Northwest Florida Blood Center, Inc.
Biologics Blood and Blood Products for Reprocessing 4050499 Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 020 S75093 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross
Biologics Fresh Frozen Plasma 020 S75093 Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross
Biologics Red Blood Cells (Apheresis) 1553291A, 1553291B Class III Blood products, with an unacceptable hematocrit, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 1506379 Class II Blood product, labeled with an incorrect expiration date, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced 20E34887, 20E34890, 20E34899, 20E34906, 20J98100, 20J98716, 20M38841, 20M38847, 20M38849, 20M3B852, 20M38854, 20M38872, 20VB3505, 20V83514, 20V83516, 20V83519, 20E34908, 20E34910, 20J98110, 20J98713, 20J98723, 20M38831, 20M38838, 20M38857, 20M38862, 20V83510, 20M38834, 20J98721, 20M38840, 20J98684, 20E34879, 20J98698, 20J98103, 20M38870, 20V83S21, 20J98718, 20E34885, 20E34894, 20M38856, 20M38858, 20M38866, 20J98677, 20M38864, 20M38869, 20J98688, 20E34901. Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 20M38857, 20M38862, 20M38872, 20V83519, 20E34679, 20E34885, 20E34890, 20E34901, 20V83521. Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 20E34894, 20E34899, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J9B698, 20J98700, 20J98703, 20J98710, 20J98713 , 20J98716, 20J98718, 20J98721, 20J98723, 20M38831, 20M38834, 20M38838, 20M38840, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38856, 20M38858, 20M38861, 20M38864, 20M38866, 20M38869, 20M38870, 20V83505, 20V83510, 20V83514, 20V83516, 20M40659, 20M40662, 20M40664, 20M40674. Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 20M38861 Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma GN0034097; GN0034652; GN0034726; GN0035205; GN0035272; GN0035915; GN0036133 Class II Blood products, collected from a donor who subsequently reported a tattoo, were distributed DCI Biologicals Orlando LLC
Biologics Platelets 1770441;1770439;1770438 Class II Blood products, labeled with the incorrect expiration date, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Frozen Rejuvenated 1770439 Class II Blood products, labeled with the incorrect expiration date, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Leukocytes Reduced Irradiated 4084307 Class II Blood product, processed in a manner that may have compromised sterility, was distributed. Northwest Florida Blood Center, Inc.
Biologics Source Plasma GN0045072; GN0045321; GN0046053; GN0048378; GN0049724; GN0049924; GN0050812; GN0051396; GN0051675; GN0053084; GN0053446; GN0054588; GN0055530; GN0055783; GN0057930; GN0058194; GN0058694; GN0059013; GN0059781; GN0060131; GN0061476; GN0061595; GN0062439; GN0063114; GN0063386; GN0063819; GN0064254; GN0064881; GN0065184. Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. DCI Biologicals, Orlando LLC
Biologics Red Blood Cells 1718381 Class III Blood product, stored at the incorrect temperature, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma 372020203; 372018910; 372018366; 372017462; 372028422; 372016374; 372014846; 372013772; 372013335; 372007234; 372000364; 372000335 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. International BioResources, LLC
Biologics Source Plasma I65076717; I65070365 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. International BioResources, LLC
Biologics Red Blood Cells Leukocytes Reduced 20LP81716 Class II Blood products, collected in a manner that may have compromised sterility, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 4111626 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Florida Blood Services, Inc.
Biologics Platelets 72F887558 Class II Quality Control and Distribution/Distribution of product that did not meet specifications. Product in which instrument QC or validation was unacceptable, incomplete, not performed, or not documented. LifeSouth Community Blood Centers, Inc.
Devices Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use. Lot: hCG2080330 Class III Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types. Alere San Diego, Inc.
Biologics Red Blood Cells W038608281767 Class III Blood product, collected from a donor with no documentation of an arm inspection, was distributed. Suncoast Communities Blood Bank, Inc.
Biologics Fresh Frozen Plasma W038608281767 Class III Blood product, collected from a donor with no documentation of an arm inspection, was distributed. Suncoast Communities Blood Bank, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 72H259365 Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced 72H552220 Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers, Inc.
Drugs Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8. Lot # 82507 and 82720. Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. Aaron Industries Inc
Biologics Source Plasma 3740083441; 3740082841; 3740080126; 3740079058; 3740078680; 3740077894; 3740077329; 3740076349; 3740075984; 3740074225; 3740073916; 3740072958; 3740072504; 3740071276; 3740070953; 3740069648; 3740086734; 3740086219; 3740075209; 3740069079; 3740068171 Class III Blood products, collected from a donor who failed arm inspection and/or general appearance, were distributed. Talecris Plasma Resources, Inc.
Devices TD-Synergy. Laboratory Information System. TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373 Class II Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. Technidata S.A.
Devices Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. product code1221-36-452, lot 187460. Class II DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012. DePuy Orthopaedics, Inc.
Food Chicken Spring Rolls Dist. by Whole Foods Market, UPC 225757203997 All product with a sell by date of 10/1/12 or 10/2/12. Class I The products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella. Whole Foods Market
Food Peanut Sesame Noodles Dist. by Whole Foods Market, UPC 222099604192 All product with either a sell by date of 10/1/12 or 10/2/12 or a sold on date of 09/27/12 or 9/28/12. Class I The products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella. Whole Foods Market
Food Goldenbrook Farms Peanut Butter Bash Ice Cream, 1/2 gallon carton with UPC code 0009282530538 All Peanut Butter Bash Ice Cream distributed between May 2010 and September 2012 with UPC code 0009282530538. Class I The product has the potential to be contaminated with Salmonella. The peanut butter used in the manufacturing of the ice cream was supplied by Sunland, Inc. Brookshire Grocery Company Manufacturing
Veterinary Priority Total Pet Care, All Natural Bullstrips Dog Treats, 6 Bullstrip, Distributed by Lucerne Foods, Inc., P.O. Box 99, Pleasanton, CA 94566-0009. UPC 0-21130-42080-3, Lot #20082712 S 3195 and 20090312 S3195 Class I Product tested positive for Salmonella. Carolina Prime Pet
Biologics Red Blood Cells Leukocytes Reduced Irradiated Washed W066512427602 Class II Blood product, collected from a donor who received a tattoo, was distributed. Blood Bank of Alaska, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W065612049423 Class II Blood product, which did not meet acceptable product specifications, was distributed. Bergen Comm Reg Blood Center
Biologics Red Blood Cells Leukocytes Reduced W1165123178833 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Ogden Medical Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W287012007860; W287012007860; W287012007897; W287012007897; W287012007912; W287012007936; Class II Blood products, which did not meet the acceptable product specifications, were distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W12701283116500 Class III Blood product, collected from a therapeutic donor, was distributed. ONEBLOOD Inc DBA: Southeastern Comm. Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W045011067606-part 1; W045011067606-part 2 Class III Blood products, collected from a donor who was at risk for Leishmaniasis, were distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing W037912183934; W037912163660; W037912139385 Class III Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W087612063608 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W0397126194597 Class II Blood product, collected from a donor who was at risk for HIV Group O, was distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Platelets Pooled Leukocytes Reduced W037912556178 Class III Blood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed. LifeServe Blood Center
Biologics Platelets Pooled Leukocytes Reduced Irradiated W037912556179 Class III Blood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W068512202667; W068512382308 Class III Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W068511031449 Class III Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells Leukocytes Reduced W068512601781; W068512022191; W068512103816; W068512210571; W068512022307; W068512103830; W068512322177; W068512382313; W068512501917; W068512501915; W068511106868; W068512200074; W068511106838; W068511323195; Class III Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed. Inland Northwest Blood Center
Biologics Plasma Frozen within 24 hours (FP24) W333612096391 Class II Blood product, expired unit returned to the firm was inappropriately re-labeled, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced Irradiated W067112078593; W067112060745 Class II Blood products, which were incompletely irradiated, were distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells W036810186644 Class II Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810811695 Class II Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036810186644 Class II Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma 12HINC1435; 12HINC0838 Class III Blood products, collected from a donor who was listed as a permanent deferral, were distributed. Bio-Blood Components, Inc.
Biologics Blood and Blood Products for Reprocessing 36FP39434 Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. The American National Red Cross South Carolina Region
Veterinary NutriPet Natural Chicken Fillet Strips, Item # 76-0081, Net wt. 16oz. There is NO UPC for this product. Product is labeled in parts: "***NUTRIPET***Naturally Chicken Fillet Strips***95% Fat-Free Treats for Dogs***NET WT. 16 oz***76-0081***". Lot 2095 and expiration date 07/2014. Class I Nutri-Pet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Glucosamine for Dogs Promotes Joint Health, has net weight 5 oz or 15 oz. The 5 oz. package, item 50704, has the UPC 6 69125 50704 9. The 15 oz package, item 50705, has the UPC 6 69125 50705 6. Product is labeled in parts: "***NUTRIVET***Naturally Chicken Breast Treats***with glucosamine for Dogs Promote Joint Health***". 5 oz packages have lot 072114 and expiration date 07/2014. 15 oz. packages have lot 061114 and 061514 and expiration date 06/2014. Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Omega 3 for Dogs Promotes a Glossy Coat has a net weight 5 oz or 15 oz. The 5 oz. package, item 50706, has the UPC 6 69125 50706 3; The 15 oz package, item 50707, has the UPC 6 69125 50707 0; Product is labeled in parts: "***NUTRIVET***Natural Chicken Breast Treats*** with Omega 3 for Dogs Promotes a Glossy Coat***". 5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 061514 and expiration date 06/2014. Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50708, has the UPC 6 69125 50708 7. The 15 oz package, item 50709, has the UPC 6 69125 50709 4. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats***with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety***". 5 oz. packages have lot 072214 and expiration date 07/2014. 15 oz. packages have lot 060714 and 061514 and expiration date 06/2014. Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Rosemary and Parsley for Dogs Promotes Fresh Breath, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50710, has the UPC 6 69125 50710 0. The 15 oz package, item 50711, has the UPC 6 69125 50711 7. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** with Rosemary and Parsley for Dogs Promotes Fresh Breath***". 5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 060714 and 060814 and expiration date 06/2014. Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Antioxidants for SENIOR Dogs Promotes Health and Vitality. Item number is 50712 and has net weight 5 oz. The UPC is 6 69125 50712 4 Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** Antioxidants for SENIOR dogs Promotes Health and Vitality***". Lot number 062914 and expiration date 06/2014 Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion. Item number is 50714, net weight 5 oz, and the UPC is 6 69125 50714 8. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion***". lot number 072614 and expiration date 07/2014 Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats with L-Carnitine for Dogs Promotes Healthy Weight. The net weight is 5 oz, item number is 50716. The UPC is 6 69125 50716 2. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** with L-Carnitine for Dogs Promotes Healthy Weight.***". lot number 072514 and expiration date 07/2014 Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Natural Chicken Breast Treats for Dogs, 5 oz. package, Item 50701, has the UPC 6 69125 50701 8; Nutri-Vet K9 Natural Chicken Breast Treats, 8 oz. package, Item 50702, has the UPC 6 69125 50702 5; Nutri-Vet K9 Natural Chicken Breast Treats, 16 oz. package, Item 50703, has the UPC 6 69125 50703 2; Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats for Dogs***VETERINARY FORMULATED***". 5 oz packages have lot code 072514 and expiration date 07/2014. 8 oz. packages have lot code 072514 and expiration date 07/2014. 16 oz. packages have lot code 061214 and 061414 and expiration date 06/2014/ Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Nutri-Vet Hip & Joint Natural Chicken Breast Strips, 100 mg glucosamine per oz. Product has item number 99044, net weight of 8 oz, and the UPC is 6 69125 99044 5. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast STRIPS***Early care for dogs***100 mg glucosamine per oz***Hip & Joint***". lot code 072714 and expiration date 07/2014 Class I Nutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella. Nutri-Vet, LLC
Veterinary Ultra Blend Gourmet, Food for Parakeets (80 oz bag), A Harvest Celebration FOOD FOR PARAKEETS, NET.WT 80 OZ (5 LBS) Eight In One Pet Products Distributed by United Pet Group, Inc., Cincinnati, OH 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00904 Item # A904/056-0904-01 - USE BY dates: 07/20/15 and 10/20/15 Class I The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella. United Pet Group Inc
Veterinary eCotrition Grains & Greens, Nutritional Supplement for Parakeets A Diverse Blend of Garden Vegetables & Select Grains Vitamin & Mineral Enriched NEW WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00505 Item # A505/11-20700 USE BY dates: 10/23/15 and 11/14/15 Class I The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella. United Pet Group Inc
Veterinary eCotrition Grains & Greens, Nutritional Supplement for Canaries and Finches A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00546 Item # C546/11-20712 - USE BY date: 10/16/15 Class I The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella. United Pet Group Inc
Veterinary eCotrition Grains & Greens, Nutritional Supplement for Cockatiels A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 6.5 OZ (184 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00512 Item # B512/11-20711 USE BY date: 12/05/15 Class I The firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella. United Pet Group Inc
Devices Molift Smart SWL150 kg Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another. Art #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058. Class II The Molift Smart (now known as the Molift Smart 150) is a foldable, mobile hoist with a safe working load ("SWL") of 150 kg (approximately 330 lbs.) and is intended for lifting and transferring a disabled person. The hoist is made out of lightweight materials for ease of operation. It has castors and is battery-powered. The Molift Smart includes a leg spreading mechanism to give optimal functionality to the product. If not assembled correctly with the locking devices, failure of the hoist may result in collapsing. Molift Inc.
Devices Molift Smart 150 Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another. Art #: 0920008; Serial Number range 20941 to 27299. Class II The Molift Smart 150 (formerly "Molift Smart") is a foldable, mobile, battery-powered hoist for lifting and transfer of disabled persons, with a safe working load ("SWL") of 150 kg (approximately 330 lbs.). The hoist includes a leg-spreading mechanism, equipped with a safety mechanism, to give optimal safety and functionality to the device. Molift Inc.
Devices PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation. Lot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01. Class II Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. Unimed Surgical Products, Inc.
Devices Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. VP1600 Class II The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. Linvatec Corp. dba ConMed Linvatec
Devices Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. System Code #728255, Serial #: 9702, 9703, 9704, 9705, 9706, 9707, 9709, 9710, 9713, 9714, 9717, 9718, 9719, 9721, 9722, 9723, 9724, 9725, 9727, 9730, 9731, 9732, 9733, 9734, 9735, 9738, 9739, 9740, 9741, 9742, 9743, 9746, 9747, 9749, 9752, 9753, 9756, 9758, 9759, 9760, 9761, 9762, 9765, 9766, 9768, 9769, 9770, 9772, 9774, 9778, 9780, 9781, 9783, 9784, 9786, 9787, 9790, 9791, 9792, 9793, 9796, 9797, 9801, 9805, 9807, 9808 & 9810. System Code #728250, Serial #: 2556, 2557, 2560, 2562, 2563, 2565, 2567, 2568, 2569, 2570, 2571, 2574, 2576, 2577, 2579, 2580, 2581, 2584, 2585, 2587, 2588, 2590, 2591, 2592, 2593, 2594, 2595, 2597, 9738 & 9741. System Code #728245, Serial #: 2562, 2564, 2567, 2573, 2576, 2582, 2584, 2585, 2586, 2587, 2589, 2590, 2594, 2596, 2597, 3014, 3091, 3105, 3151, 3217, 3235, 3287, 3303, 3312, 3339, 3340, 3341, 3342, 3343, 3344, 3346, 3348, 3351, 3353, 3355, 3356, 3357, 3358, 3359, 3360, 3363, 3364, 3366, 3369, 3371, 3373, 3374, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3385, 3388, 3392, 3393, 3394, 3397, 3400, 3404, 3406, 3407, 3408, 3410, 3413, 3414, 3415, 3416, 3419, 3423, 3425, 3427, 3429, 3431, 3432, 3433, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3443, 3445, 3446, 3448, 3449, 3451, 3452, 3453, 3454, 3455, 3458, 3459, 3461, 3462, 3464, 3468, 3469, 3470, 3471, 3473, 3474, 3475, 3477, 3478, 3479, 3481, 3482, 3483, 3484, 3485, 3486, 3488, 3489, 3491, 3492, 3493, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3517, 9716, 9718, 9719, 9724, 9732, 9741, 9743, 9746, 9749, 9778, 9780, 9787, 9790, 9797, 9801, 9808 & 9810. System Code #728120, Serial #: 2502, 2510, 2513, 2516, 2517, 2518, 2525, 2528, 2531, 2533, 2535, 2539, 2546, 3006, 3008, 3013, 3014, 3021, 3025, 3026, 3027, 3028, 3029, 3030, 3035, 3037, 3039, 3040, 3043, 3044, 3047, 3049, 3050, 3051, 3053, 3054, 3056, 3059, 3061, 3062, 3063, 3064, 3068, 3069, 3070, 3072, 3073, 3075, 3076, 3077, 3078, 3079, 3081, 3082, 3084, 3085, 3087, 3088, 3089, 3091, 3093, 3094, 3095, 3097, 3099, 3100, 3103, 3104, 3105, 3106, 3107, 3108, 3110, 3111, 3112, 3113, 3114, 3116, 3117, 3118, 3119, 3120, 3121, 3122, 3124, 3125, 3126, 3127, 3129, 3130, 3131, 3132, 3135, 3136, 3137, 3138, 3141, 3143, 3144, 3146, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3157, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3167, 3168, 3169, 3171, 3172, 3174, 3176, 3177, 3178, 3179, 3180, 3182, 3183, 3185, 3187, 3188, 3189, 3190, 3192, 3194, 3195, 3196, 3198, 3199, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3211, 3212, 3213, 3214, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3229, 3230, 3232, 3233, 3234, 3235, 3236, 3237, 3238, 3239, 3240, 3245, 3246, 3247, 3248, 3250, 3251, 3252, 3253, 3254, 3255, 3258, 3261, 3262, 3264, 3265, 3266, 3268, 3269, 3270, 3271, 3273, 3274, 3277, 3279, 3280, 3281, 3283, 3284, 3285, 3287, 3289, 3290, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3302, 3303, 3304, 3305, 3307, 3308, 3310, 3311, 3312, 3315, 3316, 3318, 3319, 3320, 3321, 3322, 3324, 3328, 3329, 3330, 3367 & 9760. System Code #728125, Serial #: 2501, 2505, 2508, 2509, 2513, 2515, 2516, 2522, 2523, 2524, 2525, 2526, 2529, 2530, 2531, 2533, 2534, 2535, 2539, 2540, 2542, 2543, 2548 & 2549. Class II Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information. Philips Medical Systems (Cleveland) Inc
Devices SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension. Serial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212. Class II Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge. Separation Technology, Inc.
Veterinary Isoflo; Isoflurane, USP; Nonflammable, Nonexplosive; Inhalation Anesthetic; 250 mL; For Use in Horses and Dogs; packaged in amber bottles; Product expires 8/23/14 Product Code: 5260-13-05; Lot: 24-002E Class III Canadian labeled Isoflurane was shipped to US customers. Abbott Animal Health
Devices Cobas® 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02. Class II When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluents are on board the module in parallel (i.e., Diluent Universal and Diluent MultiAssay), and Diluent Universal previously registered correctly is now being registered as Diluent MultiAssay, or vice versa. Roche Diagnostics Operations, Inc.
Devices VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin). Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014) Class III Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results. Ortho-Clinical Diagnostics
Veterinary Hypertonic Saline Solution 7.2%; Sterile - Preservative Free; For Animal Use Only; Packaged in HDPE 1000 mL bottle with a grey 30mm chlorobutyl rubber (silicone) stopper and capped with a silver tear off aluminum seal. Lot Number: 2J041; Item Number: 1HYP009 - VETONE; Expiry: 14 SEP Class II The sterility of the recalled products cannot be assured. Bimeda MTC Animal Health Inc.
Veterinary Calcium Gluconate 23% Solution; Sterile Preservative Free; FOR ANIMAL USE ONLY; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a red tear off aluminum seal. Lot Number: 2J029A; Item Number: 1CAL028, 500 mL, Bimeda Inc.; Expiry: 14 SEP Class II The sterility of the recalled products cannot be assured. Bimeda MTC Animal Health Inc.
Veterinary 50% Dextrose Injection, USP; Sterile Preservative Free; For Animal Use Only; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a silver tear off aluminum seal. Lot Number: 2J028; Item Number: 1DEX012; Expiry: 15 SEP Class II The sterility of the recalled products cannot be assured. Bimeda MTC Animal Health Inc.
Food Organics Nature's Promise Organic Cranberry Juice Blend UPC 688267036163 - 64 FL OZ (2 QT) 1.89L Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 Lot number Exp. Date 1430230351 11/15/2013 1430230561 11/26/2013 1430230701 12/10/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Publix Market Greenwise Organic Cranberry Flavored Juice Blend 64 FL OZ (2 QTS) 1.89 L UPC 041415049208 Distributed by Publix Supermarkets Inc. Lakeland, FL 33802 publix.com Lot Number Exp Date 1430230152 10/13/2013 1430230292 10/30/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food wild harvest organic apple juice 64 FL OZ (2 QTS) 1.89L UPC 011535025567 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA Lot Number Exp. Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230771 3/18/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food wild harvest organic cranberry 64 FL OZ (2 QTS) 1.89L UPC 011535500408 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA Lot Number Exp Date 1430230351 11/5/2013 1430230561 11/26/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Greenway Organic Apple Juice From Concentrate 64 FL Oz (2 QTS) 1.89L UPC 70625348405 Distributed by OnPoint Inc. 2 Paragon Drive Montvale, NJ 07645 Lot Number Exp Date 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230701 3/11/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Harris Teeter Organics Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 072036764324 Proudly distributed by Harris Teeters Mathews, NC 28105 Lot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230842 3/25/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food simple truth organic Apple Juice 100% 64 FL OZ (2 QT) 1.89 L UPC 011110834805 Distributed by The Kroger Co. Cincinnati OH 45202 Lot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230351 2/4/2014 3690230621 3/3/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food meijier Organics Cranberry Juice Net 64 FL OZ(2 QT) 1.89 L UPC 719283661562 Dist By Meijier Distribution Inc. Grand Rapids, MI 49544 Lot Number Exp Date 1430230701 12/10/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Full Circle Organic 100% Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 36800043114 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com Lot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230551 2/25/2014 3690230631 3/4/2014 3690230491 2/18/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Giant Eagle Nature's Basket Organic Apple Juice Net 64 FL OZ (2 QT) 1.89 L UPC 030034056063 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809 Lot Number Exp Date 3690230281 1/28/2014 3690230491 2/18/2014 3690230351 2/4/2014 3690230701 3/11/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Wegmans Organic Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 077890206058 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 Lot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230631 3/4/2014 3690230701 3/11/2014 3690230771 3/18/2014 3690230781 3/19/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Wegmans Organic Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 077890266892 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 Lot number Exp Date 1430230351 11/15/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Heinen's organic 100% Apple Juice 64 FL. OZ. (2QT) 1.89L UPC 020601403031 Distributed by: Heinen's, Inc, Warrensville Heights, OH 44128 Lot number Exp Date 3690230432 2/12/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Full Circle Organic 100 % Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 03600079045 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com Lot number Exp Date 1430230491 11/18/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Best Choice Clearly Organic Organic Apple Juice Net Wt 64 FL OZ (2 QT) 1.89 L UPC 070038614395 Proudly Distributed By : Associated Wholesale Grocers Inc., Kansas City, Kansas 66106 Lot number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Trader Joe's Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 00746854 Dist. & Sold Exclusively By: Trader Joe's Monrovia, CA 91016 Lot number Exp Date 3690230281 5/25/2014 3690230351 6/5/2014 3690230421 6/13/2014 3690230491 6/20/2014 3690230561 6/27/2014 3690230631 7/3/2014 3690230701 7/11/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food 1) Organics Nature's Promise Organic Apple Juice 64 FL OZ (2 QT) 1.89L UPC 688267036156 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 2) Organics Nature's Promise Organic Apple Juice 6.75 FL OZ (200 mL) UPC 688267063107 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 64 fl oz. Lot number Exp. Date 3690630281 1/28/2014 3690630351 2/4/2014 3690630421 2/11/2014 3690630561 2/25/2014 3690630631 3/4/2014 3690630701 3/11/2014 3690630841 3/25/2014 6.75 fl oz. Lot number Exp. Date 8240030101 1/10/2014 82400.0111 1/11/2014 8240030451 2/14/2014 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Giant Eagle Nature's Basket Organic Cranberry Net 64 FL OZ (2 QT) 1.89 L UPC 030034056070 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809 Lot number Exp. Date 1430230351 11/5/2013 1430230701 12/10/2013 Class II One of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb. Clement Pappas & Co., Inc.
Food Lam Sheng Kee, Frozen White Fish Ball - Shrimp Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class I The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. Win Luck Trading Inc
Food Lam Sheng Kee, Frozen White Fish Ball - Lobster Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class I The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. Win Luck Trading Inc
Food Lam Sheng Kee, Frozen White Fish Ball - Fish Package Egg, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class I The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. Win Luck Trading Inc
Food Lam Sheng Kee, Frozen White Fish Ball - Fresh Fish Cake, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class I The recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement. Win Luck Trading Inc
Devices cobas® 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. Material Number 05200881001 - all lot/serial numbers. Class II In rare instances, channel shifted results have been generated with cobas® 4800 assays run on v1.1.1 of the cobas® 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported cases, the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid. Roche Molecular Systems, Inc.
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-02 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-03 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-05 and 081712-06 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-01, 082712-01 and 111212-04 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-06 and 082712-13 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-08 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-02 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 071212-04 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-04 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-05 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot numbers 071212-07 and 082712-14 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-07 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-09 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-03 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-15 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries Lot number 082712-10 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries Lot number 082712-12 Class II Product coatings require 510K approval. Progressive Medical Inc
Devices Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG Class II Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference. Stryker Howmedica Osteonics Corp.
Devices Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. 3483171 Class II Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging. Coloplast Manufacturing US, LLC
Food Snap! crisped rice in a rice-milk chocolatey coating, 1.75 oz, dairy-free, vegan, no trans fats, no hydrogenated oils, no cholesterol, nothing artificial. Distributed by Go Max Go Foods, LLC 57 Puye Road, Santa Fe, NM 87505. UPC 899033002097 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Cleo's Peanut Butter Cups creamy peanut butter in a rice-milk chocolately coating, 1.5 oz, gluten-free, dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antiope, Santa Fe, NM 87506. UPC 899033002040 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Jokerz Candy Bar peanuts, caramel, & nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506. UPC 899033002002 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Twilight Candy Bar caramel & chocolatey nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506. UPC 899033002019 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Buccaneer Candy Bar chocolatey nougat in a a rice-milk chocolately coating, 2.0 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506. UPC 899033002026 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Thumbs Up Candy Bar. A Crunchy, Peanut Buttery Center in a a rice-milk chocolately coating, 1.3 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506. UPC 899033002064 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Mahalo Candy Bar. Coconut & almonds in a a rice-milk chocolately coating, 2.0 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506. UPC 899033002033 Class I Go Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk. Go Max Go Foods
Food Bean Sprouts: Keep Refrigerated: Ingredients: Mung Beans Net WT: 10 lbs (4.54 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. UPC 00000 20001 no codes on products Class I FDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility. Alfred Louie Inc
Food Soy Bean Sprouts: Keep Refrigerated: Ingredients:Soy Beans Net WT: 5 lbs (2.27 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. no codes on products Class II FDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility. Alfred Louie Inc
Devices Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. Model IntraOs 70 Class II The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h). Chicago X-Ray Systems, Inc.
Veterinary Cyclosporine Opth Oint 0.2%: 3 gm, 6 gm Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Cyclosporine Opth Oint 0.2%, 6 gm Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Cyclosporine Opth Soln 0.2%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Cyclosporine Opth Soln 1%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Cyclosporine Opth Soln 2%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary EDTA Opth Soln 1%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Tacrolimus Opth Soln 0.01%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Tacrolimus Opth Soln 0.02%,10 ml Opthalmic, 30 day expiration products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013 Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Veterinary Idoxuridine Opth Soln 0.1%,5 ml Opthalmic, 30 day expiration Products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. Class III The firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection. Nora Apothecary and Alternative Therapies, Inc.
Drugs Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85 Lot #: 10118124, Exp: Sept 2013 Class III Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Novartis Consumer Health
Food Orville Redenbacher's Classic Kettle Korn, sweet and salty popcorn, ready-to-eat, packaged in 5-oz/plastic bags (Unit UPC code 027000523216) and 1.5-oz/plastic bags (Unit UPC code 027000523254). 5-oz bags: Batch Code 5486234100, Best by Date SEP 02 2013; Batch Code 5486234200, Best by Date SEP 03 2013; and Batch Code 5486234300, Best by Date SEP 04 2013. 1.5-oz bags: Batch Code 5486234200, Best by Date SEP 03 2013 and Batch Code 5486234300, Best by Date SEP 04 2013. Class I The kettle korn flavored ready-to-eat popcorn product may contain ready-to-eat white cheddar flavored popcorn which may pose a hazard to health due to undeclared milk. Conagra Inc
Devices MyRay RXDC dental unit x-ray unit Model - MyRay RX DC Class II The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at maximum line current. CEFLA DENTAL GROUP
Food Krinos TAHINI ground sesame seeds, 1) Net. Wt. 1 lb (454g) in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28500-3, 2) Net. Wt. 2 lb in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28510-2 and 3) Net. Wt. 40 lb (18 kg) in plastic tub packed 1 tub per case-UPC Code 0-75013-04018-3. EXP JAN 01 2014 up to and including EXP JUN 08 2014 and EXP OCT 16 2014 up to and including EXP MAR 15 2015. Class I Salmonella contamination. Krinos Foods, Inc.
Devices LATITUDE® Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. n/a Class II Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended. Boston Scientific CRM Corp
Drugs Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03. Lot No: 3037382, Exp 09/13 Class III Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Drugs Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01 Lot #: 1098751, Exp. Mar-13 Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HB04712, Exp. Mar-13, HB08112, HC08112, Exp Apr-13, and HC11112 May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01 Lot #: 1098752, Exp. Mar-13; 1099890, Exp Apr-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HC04712, Exp. Mar-13; HD08112, Exp. Apr-13; HE08112, HD11112, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01 Lot #: 1098967, Exp. Mar-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HD04712, Exp. Mar-13; HF08112, Exp Apr-13; HF11112, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HE27211, Exp Apr-13; HE35511, Exp Jul-13; HA04112, Exp Aug-13; HC06212, Exp Sep-12. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HA27811, HC27811, Exp Apr-13; HD35311, HA00512, HB00512, exp Jul-13; HA04412, Exp Aug-13; HD06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HD31411, Exp May-13; HC04112, Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HE27811, HD27811, Exp Apr-13; HC00512, Exp Jul-13; HD04112, HE06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HC29411, Exp May-13; HD00512, Exp Jul-13; HA08912, Exp Oct-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #: HD29411, Exp May-13; HE00512, Exp Jul-13; HF062122, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01 Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01 Lot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01 Lot #: 1095209,1095211, Exp Apr-13; 1097408, 1097731, 1097732, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01. Lot #: 1096372, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01. Lot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01 Lot #r: 1095922, Exp May-13; 1097735, Exp Jul-13; 1099892, Exp Oct-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01 Lot #: 1095923, Exp May-13; 1097828, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. Lloyd Inc. of Iowa
Devices MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07 Class II Incorrect transmission of laboratory results. Medical Information Technology, Inc.
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
Drugs Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Lot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13 Class II Subpotent Drug: The products were below specification for potency at the expiry stability point. King Legacy, a wholly owned subsidiary of Pfizer
-
-