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Recall Observatory FDA recall evidence

Drug product

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

November 05, 2013

Class II

Product summary

Firm
Greenstone LLC
Event
Event 66696
Status
Terminated
Classification
Class II
Quantity
585,096 bottles
Official record key
drug-enforcement:D-746-2014

Official wording

Reason: 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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing