Reported Jul 3, 2024 · Terminated
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules…
Golden State Medical Supply Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Golden State Medical Supply Inc. · 5187 Camino Ruiz · Camarillo, CA · 93012-8601
Is this the product you have?
- 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
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012
- Lot codes and dates
- Lota) GS045371
- Exp
01/31/2025b) GS045910Exp. 01/31/2025
- Amount recalled
- 21,655 (30 count bottle), 34,149 (90 count bottle)
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
This product could cause temporary or reversible health problems — stop using it.
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