Recalls / Class II
Class IID-746-2014
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
- Affected lot / code info
- 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
Why it was recalled
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
Recalling firm
- Firm
- Greenstone LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Route 206 North, Peapack, New Jersey 07977
Distribution
- Quantity
- 585,096 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-11-05
- FDA classified
- 2014-01-17
- Posted by FDA
- 2014-01-29
- Terminated
- 2015-11-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-746-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.