D-1255-2016 Class III Terminated
FDA drug recall D-1255-2016 was initiated by Golden State Medical Supply Inc. on Jun 28, 2016 and is designated Class III. 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 The recall status is terminated (terminated Nov 28, 2016). Affected quantity: 2077 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 20, 2016
- Initiation Date
- Jun 28, 2016
- Termination Date
- Nov 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2077 bottles
Product description
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 pattern
Nationwide. No foreign distribution.
Code information
Lot# GS011709, GS012352
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1255-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026