Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Reported: April 30, 2025 Initiated: April 14, 2025 #D-0387-2025
Product Description
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc
- Units Affected
- 16,473 bottles
- Distribution
- US Nationwide.
- Location
- Berlin, CT
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10. Recalled by Breckenridge Pharmaceutical, Inc. Units affected: 16,473 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2025. Severity: Moderate. Recall number: D-0387-2025.
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