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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93422

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2023
Product types
Drug
Classifications
Class I
Statuses
Completed
Recalling firm wording
InvaGen Pharmaceuticals, 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

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53

D-0220-2024
Recall number
D-0220-2024
Initiated
November 17, 2023
Classification
Class I
Status
Completed
Quantity
1240 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: powder may leak out of the pouch

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: powder may leak out of the pouch

Code information

Lot #: NB301030, Exp. Date 03/31/2025

Distribution pattern

Nationwide within the United States