D-0862-2020 Class II Terminated
FDA drug recall D-0862-2020 was initiated by Teva Pharmaceuticals USA on February 20, 2020 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. The recall status is terminated (terminated October 6, 2020). Affected quantity: 3,695 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2020
- Initiation Date
- February 20, 2020
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,695 bottles
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.
Reason for Recall
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 1342500A, Exp 10/2020