Exact FDA event identifier

Event 89992

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

Event summary

Timeline bucket: April 11, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Torrent Pharma 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

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

D-0852-2022

Recall number: D-0852-2022
Initiated: April 11, 2022
Classification: Class II
Status: Terminated
Recalling firm: Torrent Pharma Inc
Quantity: 24,888 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: tablets cracking

Code information

Lot #s: BA34G021, BA34G022, Exp. 09/2022

Distribution pattern

Nationwide in the U.S.A