FDA recall D-0430-2015

American Health Packaging · Class II · drug

Product

Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)

Reason for recall

Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-01-06
Report date
2015-04-08
Termination date
2015-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0430-2015