D-746-2014 Class II Terminated
FDA drug recall D-746-2014 was initiated by Greenstone LLC on November 5, 2013 and is designated Class II. 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 The recall status is terminated (terminated November 24, 2015). Affected quantity: 585,096 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2014
- Initiation Date
- November 5, 2013
- Termination Date
- November 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 585,096 bottles
Product Description
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
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
Distribution Pattern
Nationwide and Puerto Rico
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