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Recall Observatory FDA recall evidence

Drug product

TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

D-451-2014

October 19, 2013

Class II

Product summary

Firm
Specialty Medicine Compounding Pharmacy
Event
Event 66566
Status
Terminated
Classification
Class II
Quantity
3000 mL
Official record key
drug-enforcement:D-451-2014

Official wording

Reason: 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.

Code information: All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08282013@8, 09192013@9, 10142013@2

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility