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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1

D-0233-2015

August 25, 2014

Class II

Product summary

Firm
Actavis Inc
Event
Event 69553
Status
Terminated
Classification
Class II
Quantity
46,676 cartons
Official record key
drug-enforcement:D-0233-2015

Official wording

Reason: Subpotent Drug

Code information: 3101178, exp Aug 2014, 3104318, exp Aug 2014, 3104319, exp Oct 2014, 3104889, exp Oct 2014, 3104891, exp Oct 2014, 3104893, exp Oct 2014, and 3106651, exp Dec 2014

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent