Recalls / Class II
Class IID-0862-2020
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.
- Brand name
- Mesalamine
- Generic name
- Mesalamine
- Active ingredient
- Mesalamine
- Route
- Oral
- NDC
- 0591-2245
- FDA application
- ANDA203817
- Affected lot / code info
- Lot #: 1342500A, Exp 10/2020
Why it was recalled
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 3,695 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-02-20
- FDA classified
- 2020-03-02
- Posted by FDA
- 2020-03-11
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0862-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.