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Recall Observatory FDA recall evidence

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

D-1255-2016

June 28, 2016

Class III

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 74558
Status
Terminated
Classification
Class III
Quantity
2077 bottles
Official record key
drug-enforcement:D-1255-2016

Official wording

Reason: 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

Code information: Lot# GS011709, GS012352

Distribution pattern: Nationwide. No foreign distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Incorrect or Missing