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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15

D-0396-2015

February 12, 2015

Class II

Product summary

Firm
Actavis Inc
Event
Event 70555
Status
Terminated
Classification
Class II
Quantity
51,472 cartons
Official record key
drug-enforcement:D-0396-2015

Official wording

Reason: Subpotent Drug

Code information: Lot #: 310935 Exp 3/31/2015; Lot #: 3109552 Exp 3/31/2015; Lot #: 3110204, Exp 3/31/2015; Lot #: 3112972, Exp 7/31/2015; Lot #: 3114073, Exp 8/31/2015; Lot #: 3115756, Exp 10/31/2015, Lot #: 3115888, Exp 10/31/2015; Lot #: 3118059, Exp 11/30/2015.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent