Why it was 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
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
Lot numbers, UPCs & expiration codes
Lot# GS011709, GS012352
Where it was sold
Nationwide. No foreign distribution.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1255-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 28, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 2077 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-1255-2016, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74558
- Address
- 5187 Camino Ruiz
- Code information
- Lot# GS011709, GS012352
- Postal code
- 93012-8601
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1255-2016
- Classification
- Class III
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 2077 bottles
- Termination date
- Nov 28, 2016
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide. No foreign distribution.
- Recall initiation date
- Jun 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2016