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Recall Observatory FDA recall evidence

Drug product

Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.

D-164-2013

January 07, 2013

Class III

Product summary

Firm
West-ward Pharmaceutical Corp.
Event
Event 64108
Status
Terminated
Classification
Class III
Quantity
1,185 Bottles
Official record key
drug-enforcement:D-164-2013

Official wording

Reason: Subpotent Drug

Code information: Lot #: 69001A

Distribution pattern: OH

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent