Recalls / Class II
Class IID-1821-2019
Product
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
- Affected lot / code info
- Lot 181677, exp 11/30/2020
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 457 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-08-09
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1821-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.