FDARecalled Apr 30, 2025 · #D-0388-2025
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distri...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Classification: Class II Distribution: US Nationwide.
Product details
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Model numbers
- 230201C
- UPCs
- —