Class II · ModerateRecall completed
sertraline HCl tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot 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
Where it was soldNationwide and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
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
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Greenstone LLC, Peapack, NJ 07977 -- |
| NDC | 59762-4960-1 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Greenstone LLC |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 585,096 bottles |
| Recall initiated | 2013-11-05 |
| Report date | 2014-01-29 |
| Recall completed | 2015-11-24 |
| Recall number | D-746-2014 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Peapack NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.