Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reported: January 1, 2025 Initiated: December 6, 2024 #D-0162-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reason for Recall
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc
- Units Affected
- 76,968 bottles
- Distribution
- Nationwide in the US
- Location
- Berlin, CT
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.. Recalled by Breckenridge Pharmaceutical, Inc. Units affected: 76,968 bottles.
Why was this product recalled? ▼
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2025. Severity: Moderate. Recall number: D-0162-2025.
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