• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

  • Print
  • Share
  • E-mail

Product Detail

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
Recall Number D-459-2014
Classification Class II
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
Product Distributed Qty a) Injectable 600 mL; b) Topical 800 mL
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.

Event Detail

Event Id 66566
Product Type Drugs
Status Ongoing
Recalling Firm Specialty Medicine Compounding Pharmacy
City South Lyon
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-19
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Hospitals, clinics, physicians, and patients in the Michigan area only.