FDA recall D-1062-2013

Core Pharma Llc · Class II · drug

Product

Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10

Reason for recall

Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2013-10-02
Termination date: 2014-08-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middlesex, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1062-2013