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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Event Detail

Event ID 66566
Product Type Drugs
Status Ongoing
Recalling Firm Specialty Medicine Compounding Pharmacy
City South Lyon
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-19
Initial Firm Notification of
Consignee or Public
Press Release
Distribution Pattern Hospitals, clinics, physicians, and patients in the Michigan area only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07122013@1, 09162013@6 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 420 mL D-447-2014
Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10022013@6, 10162013@3, t10172013@10 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 180 mL D-446-2014
Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08302013@12 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 100 mL D-445-2014
SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@11, 09242013@12, 10022013@1, 10022013@2, 10082013@1, 10082013@2, 10082013@3, 10092013@1, 10092013@2, 10092013@3, 10152013@15, 09192013@1, 09192013@2, 09192013@3, 09192013@4, 09192013@6, 09192013@7, 09192013@8, 09202013@28, 09202013@29, 10032013@3, 10032013@4, 10152013@3, 10152013@4 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 9200 mL D-444-2014
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 86 mL D-443-2014
Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@8 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 6 mL D-442-2014
POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10032013@2, 10032013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 600 mL D-441-2014
Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t07312013@28 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 10 mL D-440-2014
Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 6 mL D-439-2014
Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 07232013@41 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 11 mL D-438-2014
Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08212013@13, 09112013@2, 09172013@17, 09232013@1, 09242013@13, 10022013@7, 09242013@14, 10022013@9, 10032013@5, 10072013@2 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 1351 mL D-437-2014
Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@20, t09162013@43, t08282013@18, t08292013@11 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 35.5 mL D-436-2014
Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@8, 09242013@3, 09242013@4, 09242013@6, 09242013@7, 09242013@9, 10012013@1, 10012013@2, 10012013@3, 10012013@4, 10012013@5, 10012013@6, 10032013@6, 10142013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 5582.6 mL D-435-2014
NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@3 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 100 mL D-434-2014
NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08292013@10 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 120 mL D-433-2014
Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 186 mL D-432-2014
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10072013@4, 10192013@1, 07112013@3, 09052013@6, 09262013@2, 09272013@35, 10012013@26, 08282013@35, t08282013@17, t10092013@30, t10102013@18, t08222013@11, t08292013@21, t08302013@5, t09162013@30, 09162013@46, 09172013@23, t09242013@33, t09302013@25, t10022013@15, t10112013@21, t10162013@4, t08222013@21, t10092013@29 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 726.45 mL D-431-2014
METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 20 mL D-430-2014
Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07312013@41, 07312013@42, 07312013@43, 07312013@44, 07312013@45, 08012013@1, 08012013@2, 08012013@4, 08012013@6, 08012013@11, 08012013@3, 08012013@5, 08012013@7, 08012013@8, 08012013@9, 08012013@10 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 19200 mL D-429-2014
LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08142013@39, t09052013@40, t09122013@3, t09122013@25 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 65 mL D-428-2014
HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09192013@10, 10152013@19 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 53 mL D-427-2014
HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08122013@18, t09232013@8 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 70 mL D-426-2014
Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, 10152013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 148.075 ml D-425-2014
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 210 mL D-424-2014
Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 126 mL D-423-2014
Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@5, 10162013@2 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 38 doses D-422-2014
FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09242013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 4.4 mL D-421-2014
FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 700 mL D-420-2014
EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10082013@7, 10152013@2, t10102013@1, t10092013@7, t10092013@6, t10142013@60, t10142013@61 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 157.08 mL D-419-2014
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@36, t09182013@5 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 30 mL D-418-2014
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09112013@1, 09232013@40, t09252013@26 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 70 mL D-417-2014
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 5 mL D-416-2014
Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t08162013@15 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 180 mL D-415-2014
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@4, 10162013@1 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 38 doses D-414-2014
Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@3 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 44.44 mL D-413-2014
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: for both sizes: 08072013@26, 08282013@52, 09112013@31, 09162013@33, 10072013@33, 07242013@47, 08082013@42, 09172013@52, 10162013@35, 07242013@55, 07242013@56, 09122013@36, 09122013@35, 10042013@8, 10042013@9, 07262013@12, 07262013@13, 07262013@14, 07262013@16, 08082013@35, 08082013@41, 08152013@44, 08162013@21, 08292013@53, 08302013@24, 08302013@25, 08302013@35, 09062013@20, 09132013@26, 09132013@12, 09132013@13, 09202013@34, 09202013@35, 09202013@36, 09262013@24, 10092013@36, 10092013@39, 10102013@37, 10112013@34, 10162013@44, 10172013@26, 10172013@27 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 2801 doses D-412-2014
Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08132013@1, 08162013@5 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 160 grams D-411-2014
Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10152013@22 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 20 mL D-410-2014
SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10152013@20 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 10 mL D-460-2014
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@10, 09302013@1, 10152013@5, ; b) Topical 09252013@11, 09302013@3, 10152013@7 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. a) Injectable 600 mL; b) Topical 800 mL D-459-2014
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. a) Injectable 800 mL; b) Topical 600 mL D-458-2014
Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09202013@1, 09202013@2, 09202013@3, 09202013@4, 09202013@5, 09202013@6, 09202013@7, 09202013@8, 10102013@7, 10102013@3, 10102013@8 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 8090.8 mL D-457-2014
WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. a) 1900 injectable; b) 1900 mL topical D-456-2014
VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10012013@23, 10012013@24, 10012013@25, 10012013@9, 10012013@12, 10012013@13, 10012013@15, 10012013@16, 10012013@17, 10012013@19, 10012013@20, 10012013@22 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 204 doses D-455-2014
VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 50 mL D-454-2014
TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t09032013@48, t09252013@37, 09162013@38 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 44 mL D-453-2014
TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10142013@30 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 5.5 mL D-452-2014
TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08282013@8, 09192013@9, 10142013@2 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 3000 mL D-451-2014
QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08262013@5 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 15 mL D-448-2014
TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08192013@34, t08272013@34, t10012013@28 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 17.5 ml D-450-2014
TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09182013@42, t09172013@31, t09182013@4 Class II Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. 33 mL D-449-2014
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