Why it was recalled
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Product description
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
Lot numbers, UPCs & expiration codes
Lot 1004835, Exp 7/31/2023
Where it was sold
Nationwide in the USA
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-0892-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 23, 2023
- FDA report date
- Jul 12, 2023
- Quantity
- 4,971 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0892-2023, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 92607
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 1004835, Exp 7/31/2023
- Postal code
- 43217-1188
- Report date
- Jul 12, 2023
- Product type
- Drugs
- Recall number
- D-0892-2023
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 4,971 cartons
- Termination date
- Sep 6, 2024
- Reason for recall
- Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2023