Recalls / Class II
Class IID-0568-2024
Product
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.
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 60429-164, 60429-165, 60429-166
- FDA application
- ANDA203088
- Affected lot / code info
- Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2024-05-13
- FDA classified
- 2024-06-25
- Posted by FDA
- 2024-07-03
- Terminated
- 2025-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0568-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.