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
Product summary
- 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
Labeling; Incorrect or Missing