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Recall Observatory FDA recall evidence

Drug product

Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.

D-0567-2016

March 10, 2015

Class II

Product summary

Firm
Freedom Pharmaceuticals Inc
Event
Event 72795
Status
Terminated
Classification
Class II
Quantity
20 kg
Official record key
drug-enforcement:D-0567-2016

Official wording

Reason: Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

Code information: Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.