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Recall Observatory FDA recall evidence

Drug product

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

D-0401-2015

February 27, 2015

Class III

Product summary

Firm
AVKARE Inc.
Event
Event 70635
Status
Terminated
Classification
Class III
Quantity
214 unit dose packs
Official record key
drug-enforcement:D-0401-2015

Official wording

Reason: Subpotent Drug

Code information: Lot number: I1404952, Exp. 02/2016

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent