Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Reported: March 19, 2025 Initiated: February 28, 2025 #D-0271-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc.
- Units Affected
- 11,125 bottles.
- Distribution
- Nationwide
- Location
- Berkeley Heights, NJ
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05. Recalled by Breckenridge Pharmaceutical, Inc.. Units affected: 11,125 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 March 19, 2025. Severity: Moderate. Recall number: D-0271-2025.
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