Mesalamine Delayed-Release Tablets recall: Failed Dissolution
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.
Why was Mesalamine Delayed-Release Tablets recalled?
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1342500A, Exp 10/2020
- Product
- 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.
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 3,695 bottles
- Distribution
- Nationwide in the USA.
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)