Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per 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.
Reported: November 18, 2020 Initiated: October 28, 2020 #D-0069-2021
Product Description
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per 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: Out-of-specification dissolution results were obtained during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 133,829 bottles
- Distribution
- Nationwide in the U.S. and PR
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per 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.. Recalled by Teva Pharmaceuticals USA. Units affected: 133,829 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2020. Severity: Moderate. Recall number: D-0069-2021.
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