Why it was recalled
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Product description
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
Lot numbers, UPCs & expiration codes
Lot #: M25569, Exp 08/18
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-0857-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 68, 214 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0857-2016, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 73913
- Address
- 235 E 42nd St
- Code information
- Lot #: M25569, Exp 08/18
- Postal code
- 10017-5703
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0857-2016
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 68, 214 bottles
- Termination date
- Jul 26, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 28, 2016
- Initial firm notification
- Letter
- Center classification date
- May 20, 2016