Friday, February 14, 2014

FDA Enforcement Report Dated February 12, 2014 contains list of veterinary compounded preparations from Specialty Medicine Compounding Pharmacy

Veterinary AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE Lot t10162013@20 Best By 10/30/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary BUPRENORPHINE* HCL 0.6MG/ML INJECTABLE Lot 10112013@2 Best By11/10/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary CYCLOSPORIN* MCT 0.2% OPHTHALMIC CYCLOSPORIN* MCT 1% OPHTHALMIC CYCLOSPORIN* MCT 2% OPHTHALMIC 0.2%: Lot t08142013@42 Best By 2/10/2014 1%: Lot t07022013@29 Best By 12/29/2013; Lot t07242013@27 Best By 1/20/2014; Lot t08282013@28 Best By 2/24/2014; Lot t10032013@10 Best By 4/1/2014 2%: Lot t08142013@36 Best By 2/10/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary DESMOPRESSIN ACETATE* (0.01%) 0.1MG/ML SOLUTION DESMOPRESSIN ACETATE* (0.0125%) 0.125MG/ML DESMOPRESSIN ACETATE* (0.02%) 0.2MG/ML SOLUTION Lot 09132013@4 Best By 12/12/2013 Lot t09182013@39 Best By 12/17/2013 Lot t09032013@21 Best By 12/2/2013 Lot t07242013@22 Best By 10/22/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary DOXYCYCLINE-OS 100MG/ML VET LIQUID Lot 08092013@23 Best By 2/5/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary IDOXURIDINE* OPHTHALMIC 0.1% SOLUTION L Lot t08022013@17 Best By 9/1/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary PHENOBARBITAL SODIUM* 65MG/ML INJECTABLE Lot 08192013@28 Best By11/17/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS (VET)* 0.03% OPHTH SOL TACROLIMUS* (VET) 0.02% OPHTH SOL 0.03% : Lot 08222013@17, Best By10/21/2013 t09052013@14 11/4/2013 0.02%: Lot t08272013@17, Best By10/26/2013 t09162013@20 11/15/2013 t09262013@6 11/25/2013 t09302013@31 11/29/2013 t10092013@14 12/8/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS OINTMENT 0.03% OPHTHALMIC 08122013@39 2/8/2014 t10092013@15 4/7/2014 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary TACROLIMUS* (VET) MCT 0.02% OPHTH SOL t07092013@24 Best By 9/7/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Specialty Medicine Compounding Pharmacy
Veterinary XYLAZINE* (VET) 100MG/ML INJECTABLE t08212013@17 Best By11/20/2013 Class II Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

quoted from here

No comments: