FDA recall D-0232-2021

American Health Packaging · Class II · drug

Product

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2021-01-07
Report date: 2021-01-27
Termination date: 2022-08-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0232-2021