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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69133

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Micro Labs Usa, Inc S

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

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540

D-0046-2015
Recall number
D-0046-2015
Initiated
October 09, 2014
Classification
Class II
Status
Terminated
Recalling firm
Micro Labs Usa, Inc S
Quantity
11,328 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

Code information

GLBG001 Exp.12/14, GLBG008 Exp. 06/15

Distribution pattern

CT, FL, MD, MS, NY