FDAFDA · Food and drugs·Recall number D-746-2014
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
Published January 29, 2014 · Recall initiated: November 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Greenstone LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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