FDA recall D-1079-2014

Corepharma LLC · Class II · drug

Product

Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10

Reason for recall

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-12-13
Report date: 2014-02-12
Termination date: 2015-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middlesex, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1079-2014