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.

FDA recall notice · announced June 1, 2016 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: M25569, Exp 08/18
Quantity: 68, 214 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0857-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.