FDA recall D-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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-08-09

Report date

2019-08-21

Termination date

2020-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1821-2019