Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Lot numbers, UPCs & expiration codes
Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Where it was sold
Nationwide in the U.S.
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-0568-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2024
- FDA report date
- Jul 3, 2024
- Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0568-2024, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 94639
- Address
- 5187 Camino Ruiz
- Code information
- Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
- Postal code
- 93012-8601
- Report date
- Jul 3, 2024
- Product type
- Drugs
- Recall number
- D-0568-2024
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Termination date
- Mar 20, 2025
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- May 13, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2024