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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75205

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 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

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 Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.

D-1519-2016
Recall number
D-1519-2016
Initiated
August 19, 2016
Classification
Class III
Status
Terminated
Quantity
368 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

Code information

Lot #: GLEH 16003, Exp 03/31/18

Distribution pattern

Nationwide