FDA recall D-0857-2016

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-04-28

Report date

2016-06-01

Termination date

2017-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0857-2016