Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Reported: September 17, 2025 Initiated: August 8, 2025 #D-0621-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Reason for Recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc.
- Units Affected
- 3,591 bottles
- Distribution
- AZ, IN, NJ
- Location
- Berkeley Heights, NJ
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10. Recalled by Breckenridge Pharmaceutical, Inc.. Units affected: 3,591 bottles.
Why was this product recalled? ▼
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 17, 2025. Severity: Moderate. Recall number: D-0621-2025.
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