Why it was recalled
GMP Deviation: lot not intended for commercial distribution.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 1344864A, exp. date 10/2020
Where it was sold
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.
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-0131-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 5,849 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0131-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83730
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 1344864A, exp. date 10/2020
- Postal code
- 07054-1120
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0131-2020
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 5,849 bottles
- Termination date
- May 19, 2020
- Reason for recall
- GMP Deviation: lot not intended for commercial distribution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- 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.
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019