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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76457

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RemedyRepack Inc.

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

Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02

D-0482-2017
Recall number
D-0482-2017
Initiated
February 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
630 pills (21 bottles x 30 pills per HDPE bottle)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC

Distribution pattern

Product was distributed to a sold customer in FL.