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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66696

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

Open FDA event record

Event summary

Timeline bucket
November 05, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Greenstone LLC

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

sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1

D-746-2014
Recall number
D-746-2014
Initiated
November 05, 2013
Classification
Class II
Status
Terminated
Recalling firm
Greenstone LLC
Quantity
585,096 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life

Code information

Lot SASA12001-A, exp. date 06/2015; Lot SASA12001-B, exp. date 06/2015; Lot SASA13001-A, exp. date 02/2016; Lot SASA13002-A, exp. date 02/2016

Distribution pattern

Nationwide and Puerto Rico