Class II
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 20, 2020
- Posted
- March 11, 2020
- Recall Number
- D-0862-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,695 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot #: 1342500A, Exp 10/2020
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