Recalls / Class II
Class IID-1302-2022
Product
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
- Brand name
- Matzim La
- Generic name
- Diltiazem Hydrochloride
- Active ingredient
- Diltiazem Hydrochloride
- Route
- Oral
- NDCs
- 52544-691, 52544-692, 52544-693, 52544-694, 52544-695
- FDA application
- ANDA077686
- Affected lot / code info
- Lot 1411593A, Exp 09/22
Why it was recalled
Failed Dissolution Specifications: below specification limits for dissolution.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 8022 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-1302-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.