Specialty Medicine Compounding Pharmacy recalls WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Me
Recalled January 22, 2014 · FDA recall D-456-2014 · Specialty Medicine Compounding Pharmacy
Hazard
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. · FDA Class II
Units
a) 1900 injectable; b) 1900 mL topical
Sold at
Hospitals, clinics, physicians, and patients in the Michigan area only.
Description
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.
Product
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
Manufacturer(s)
Specialty Medicine Compounding Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →