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.
Reported: March 11, 2020 Initiated: February 20, 2020 #D-0862-2020
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 3,695 bottles
- Distribution
- Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 3,695 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2020. Severity: Moderate. Recall number: D-0862-2020.
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