Class II
Terminated
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.
- Company
- Golden State Medical Supply Inc.
- Recall Initiated
- May 13, 2024
- Posted
- July 3, 2024
- Recall Number
- D-0568-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Firm Location
- Camarillo, CA, United States
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
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