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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74953

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

Open FDA event record

Event summary

Timeline bucket
August 19, 2016
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Impax Laboratories, 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

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

D-0215-2017
Recall number
D-0215-2017
Initiated
August 19, 2016
Classification
Class I
Status
Terminated
Recalling firm
Impax Laboratories, Inc.
Quantity
3,074 boxes (30 count boxes)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Label Mixup

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Code information

Lot Number 502240, expiry date 11/2017

Distribution pattern

Distributed Nationwide