Why it was recalled
Failed Dissolution Testing: Failed 24 month dissolution testing.
Product description
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
Lot numbers, UPCs & expiration codes
Lot #: 98016P1, Expiry: April, 2016
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1348-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 2,916 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ucb, Inc
Original FDA data
Every field from FDA enforcement report D-1348-2015, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 71986
- Address
- 1950 Lake Park Dr Se
- Code information
- Lot #: 98016P1, Expiry: April, 2016
- Postal code
- 30080-7648
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1348-2015
- Classification
- Class II
- Recalling firm
- Ucb, Inc
- Product quantity
- 2,916 Bottles
- Termination date
- Jul 19, 2017
- Reason for recall
- Failed Dissolution Testing: Failed 24 month dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jul 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2015