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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90709

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

Open FDA event record

Event summary

Timeline bucket
September 19, 2022
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

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01

D-1541-2022
Recall number
D-1541-2022
Initiated
September 19, 2022
Classification
Class III
Status
Terminated
Quantity
18,960 bottles of 100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Code information

Lot # GCLH22005, exp. date 02/29/2024

Distribution pattern

Distributed Nationwide in the USA