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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description Pyridostigmine Bromide Tablets, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Recall Number D-1062-2013
Classification Class II
Code Info 109497; Exp. 12/15
Product Distributed Qty 960 bottles
Reason For Recall Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.

Event Detail

Event Id 65889
Product Type Drugs
Status Ongoing
Recalling Firm Core Pharma Llc
City Middlesex
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide