The Recall Desk
ModerateFDA (Drugs)·D-1079-2014·Announced 2014-02-12

Corepharma Recalls Pyridostigmine Bromide Tablets Due to Dissolution Failure

Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP 60 mg because they failed a dissolution test at the 30-month stability time point.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottles, due to an out-of-specification dissolution test generated at the 30-month stability time point. The affected product is prescription-only and was manufactured and distributed by Corepharma, LLC in Middlesex, NJ.

The recall involves 174,888 bottles distributed nationwide and in Puerto Rico. Specific lot numbers and expiration dates are listed in the source data, ranging from December 2013 to May 2015.

Consumers should stop using the recalled product and consult their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

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
Manufacturer
Corepharma LLC
Category
Drug — Prescription Medication
Hazard
Affected units
174,888

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · dissolution failure

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