Exact FDA event identifier

Event 88891

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

Event summary

Timeline bucket: October 25, 2021
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: UNICHEM PHARMACEUTICALS USA 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.

D-0255-2022

Recall number: D-0255-2022
Initiated: October 25, 2021
Classification: Class III
Status: Terminated
Recalling firm: UNICHEM PHARMACEUTICALS USA INC
Quantity: 1284 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration

Code information

Lot #: ZTPM20044, Exp. Date 09/30/2022

Distribution pattern

Nationwide within the United States