univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
FDA recall notice · announced August 26, 2015 · Ucb
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
Reason for recall
Failed Dissolution Testing: Failed 24 month dissolution testing.
Notes
Distribution: U.S. Nationwide
Lot/code information: Lot #: 98016P1, Expiry: April, 2016
Quantity: 2,916 Bottles
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.