June 2016 FDA Recall Duloxetine by Golden State Medical Supply Inc.
D-1255-2016 - 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
This Class III drug recall was voluntarily initiated by Golden State Medical Supply Inc. on June 28, 2016 for the product Duloxetine. The FDA reported the reason for recall as 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. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1255-2016
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
06-28-2016
07-20-2016
2077 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
11-28-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# GS011709, GS012352
