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Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distribute...

FDA Recall #D-1079-2014 — Class II — December 13, 2013

Recall #D-1079-2014 Date: December 13, 2013 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Corepharma LLC — Middlesex, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

174,888 Bottles

Distribution

Nationwide and Puerto Rico

Code Information

Lot #s and Exp dates: 106019 exp December-13 106020 exp December -13 106336 exp January-14 106337 exp January-14 106338 exp January-14 106097 exp February-14 106098 exp February-14 106099 exp February-14 106100 exp April-14 106545 exp April-14 106664 exp April-14 107208 exp July-14 107363 exp October-14 107574 exp October-14 107629 exp October-14 108167 exp February-15 108168 exp February-15 108169 exp February-15 108322 exp May-15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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