Why it was recalled
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Product description
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
Lot numbers, UPCs & expiration codes
Lot: S84026
Where it was sold
Nationwide in the USA
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-0151-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 20, 2017
- FDA report date
- Jan 10, 2018
- Quantity
- 1972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0151-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78332
- Address
- 235 E 42nd St
- Code information
- Lot: S84026
- Postal code
- 10017-5703
- Report date
- Jan 10, 2018
- Product type
- Drugs
- Recall number
- D-0151-2018
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1972 bottles
- Termination date
- Jun 2, 2020
- Reason for recall
- SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2018