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
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-746-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 5, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 585,096 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Greenstone LLC
Original FDA data
Every field from FDA enforcement report D-746-2014, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66696
- Address
- 100 Route 206 North
- 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
- Postal code
- 07977
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-746-2014
- Classification
- Class II
- Recalling firm
- Greenstone LLC
- Product quantity
- 585,096 bottles
- Termination date
- Nov 24, 2015
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 5, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2014