Recalls / Class II
Class IID-1303-2022
Product
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
- Affected lot / code info
- Lot 1411596A, Exp 09/22
Why it was recalled
Failed Dissolution Specifications: below specification limits for dissolution.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 5677 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-07-21
- FDA classified
- 2022-08-04
- Posted by FDA
- 2022-08-10
- Terminated
- 2023-04-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1303-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.