Recalls / Class II

Class IID-459-2014

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

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

Specialty Medicine Compounding Pharmacy

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

350 S Lafayette St, South Lyon, Michigan 48178-1814

Distribution

Quantity

a) Injectable 600 mL; b) Topical 800 mL

Distribution pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

Timeline

Recall initiated

2013-10-19

FDA classified

2014-01-10

Posted by FDA

2014-01-22

Terminated

2014-09-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-459-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.