Specialty Medicine Compounding Pharmacy recalls DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topic
Recalled January 22, 2014 · FDA recall D-459-2014 · 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) Injectable 600 mL; b) Topical 800 mL
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
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
Manufacturer(s)
Specialty Medicine Compounding Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →