Recalls / Class II
Class IID-1348-2015
Product
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
- Affected lot / code info
- Lot #: 98016P1, Expiry: April, 2016
Why it was recalled
Failed Dissolution Testing: Failed 24 month dissolution testing.
Recalling firm
- Firm
- Ucb, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1950 Lake Park Dr Se, Smyrna, Georgia 30080-7648
Distribution
- Quantity
- 2,916 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-08-19
- Posted by FDA
- 2015-08-26
- Terminated
- 2017-07-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1348-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.