Why it was recalled
Failed Dissolution Specifications
Product description
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
Lot numbers, UPCs & expiration codes
Lot 181677, exp 11/30/2020
Where it was sold
Nationwide 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-1821-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 9, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 457 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1821-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83559
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 181677, exp 11/30/2020
- Postal code
- 43217-1188
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1821-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 457 cartons
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 9, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2019