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Recall Observatory FDA recall evidence

Drug product

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01

D-323-2014

August 02, 2013

Class II

Product summary

Firm
American Health Packaging
Event
Event 66451
Status
Terminated
Classification
Class II
Quantity
1536 cartons
Official record key
drug-enforcement:D-323-2014

Official wording

Reason: Subpotent

Code information: The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent