Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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