Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reported: May 15, 2024 Initiated: April 29, 2024 #D-0482-2024
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), 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
- 281,554/90 & 1000 count bottles
- Distribution
- US Nationwide.
- Location
- Berlin, CT
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), 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: 281,554/90 & 1000 count 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 May 15, 2024. Severity: Moderate. Recall number: D-0482-2024.
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