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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67291

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 13, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Corepharma LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1079-2014
Recall number
D-1079-2014
Initiated
December 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
Corepharma LLC
Quantity
174,888 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

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

Distribution pattern

Nationwide and Puerto Rico