Reported Mar 11, 2020 · Terminated
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 |
| 2 | Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 |
| 3 | NDC 0591-2245-22. |
- Lot codes and dates
Lot #: 1342500AExp 10/2020
- Amount recalled
- 3,695 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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