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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.

D-1386-2014

May 16, 2014

Class II

Product summary

Firm
Actavis Inc
Event
Event 68453
Status
Terminated
Classification
Class II
Quantity
6913 packages
Official record key
drug-enforcement:D-1386-2014

Official wording

Reason: Subpotent Drug.

Code information: Lot #: 3100135, Expiry: 05/2014

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent