D-459-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- October 19, 2013
- Termination Date
- September 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) Injectable 600 mL; b) Topical 800 mL
Product Description
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
Reason for Recall
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.
Distribution Pattern
Hospitals, clinics, physicians, and patients in the Michigan area only.
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