Status
Terminated
Drug Enforcement D-0568-2024
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Classification
Class II
Report Date
July 3, 2024
Termination Date
March 20, 2025
Product Information
- 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.
- Product quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.
Location & Firm
- Recalling firm
- Golden State Medical Supply Inc.
- Address
-
5187 Camino Ruiz
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0568-2024
- Event ID
- 94639
- Recall initiation date
- May 13, 2024
- Center classification date
- June 25, 2024
- Code info
- Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
- More code info
- —