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Recall Observatory FDA recall evidence

Drug product

univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.

D-1348-2015

July 24, 2015

Class II

Product summary

Firm
Ucb, Inc
Event
Event 71986
Status
Terminated
Classification
Class II
Quantity
2,916 Bottles
Official record key
drug-enforcement:D-1348-2015

Official wording

Reason: Failed Dissolution Testing: Failed 24 month dissolution testing.

Code information: Lot #: 98016P1, Expiry: April, 2016

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Dissolution Testing: Failed 24 month dissolution testing.