FDA recall D-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

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

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

Key facts

Status

Terminated

Initiation date

2013-10-19

Report date

2014-01-22

Termination date

2014-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Lyon, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-459-2014