Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division o...

FDA Recall #D-0151-2018 — Class II — October 20, 2017

Recall #D-0151-2018 Date: October 20, 2017 Classification: Class II Status: Terminated

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

Reason for Recall

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Recalling Firm

Pfizer Inc. — New York, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1972 bottles

Distribution

Nationwide in the USA

Code Information

Lot: S84026

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated