Why it was recalled
Failed Dissolution Specifications: below specification limits for dissolution.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot 1411596A, Exp 09/22
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1303-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 21, 2022
- FDA report date
- Aug 10, 2022
- Quantity
- 5677 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1303-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90635
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot 1411596A, Exp 09/22
- Postal code
- 07054-1120
- Report date
- Aug 10, 2022
- Product type
- Drugs
- Recall number
- D-1303-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 5677 bottles
- Termination date
- Apr 18, 2023
- Reason for recall
- Failed Dissolution Specifications: below specification limits for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 21, 2022
- Center classification date
- Aug 4, 2022