FDA recall D-746-2014

Product

sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1

Reason for recall

Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-11-05

Report date

2014-01-29

Termination date

2015-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peapack, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-746-2014