FDA recall D-0151-2018

Product

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-20

Report date

2018-01-10

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2018