FDA-Drug2014-01-22Class II
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
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.
Sold states
Hospitals, clinics, physicians, and patients in the Michigan area only.
Affected count
a) Injectable 600 mL; b) Topical 800 mL
Manufactured in
350 S Lafayette St, South Lyon, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-459-2014Don't want to check this manually?
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