FDA recall D-1255-2016

Golden State Medical Supply Inc. · Class III · drug

Product

DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10

Reason for recall

Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018

Distribution

Nationwide. No foreign distribution.

Key facts

Status: Terminated
Initiation date: 2016-06-28
Report date: 2016-07-20
Termination date: 2016-11-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1255-2016