FDAClass IIIJuly 20, 2016

DULOXETINE Delayed-Release Capsules recall: Labeling Error

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

Why was DULOXETINE Delayed-Release Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# GS011709, GS012352

Product
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona…
Recalling firm
Golden State Medical Supply Inc.
Quantity
2077 bottles
Distribution
Nationwide. No foreign distribution.
Recall date
July 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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