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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15

D-0406-2015

February 12, 2015

Class II

Product summary

Firm
Actavis Inc
Event
Event 70555
Status
Terminated
Classification
Class II
Quantity
29,405 cartons
Official record key
drug-enforcement:D-0406-2015

Official wording

Reason: Subpotent Drug

Code information: Lot #: 3109554, Exp 3/31/2015; Lot #: 3111457, Exp 3/31/2015; Lot #: 3112973, Exp 7/31/2015; Lot #: 3114262, Exp 6/30/2015; Lot #: 3114076, Exp 12/31/2015; Lot #: 3115889, Exp 12/31/2015; Lot #: 3116033, Exp 12/31/2015.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent