Drug 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
D-459-2014
Product summary
- Event
- Event 66566
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) Injectable 600 mL; b) Topical 800 mL
- Official record key
drug-enforcement:D-459-2014
Official wording
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.
Code information: 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
Distribution pattern: Hospitals, clinics, physicians, and patients in the Michigan area only.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility