Recalls / Class III
Class IIID-0131-2020
Product
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30
- 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 # 1344864A, exp. date 10/2020
Why it was recalled
GMP Deviation: lot not intended for commercial distribution.
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
- 5,849 bottles
- Distribution pattern
- Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico.
Timeline
- Recall initiated
- 2019-09-06
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0131-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.