Why it was recalled
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Product description
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
Lot numbers, UPCs & expiration codes
Lot #: 1342500A, Exp 10/2020
Where it was sold
Nationwide in the USA.
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-0862-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 20, 2020
- FDA report date
- Mar 11, 2020
- Quantity
- 3,695 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0862-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85017
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 1342500A, Exp 10/2020
- Postal code
- 07054-1120
- Report date
- Mar 11, 2020
- Product type
- Drugs
- Recall number
- D-0862-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 3,695 bottles
- Termination date
- Oct 6, 2020
- Reason for recall
- Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2020