Reported Jun 26, 2024 · Terminated
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
Breckenridge Pharmaceutical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist
- byBreckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
- Lot codes and dates
Lot #: 230035CExp. date 11/30/2025230101CExp. date 12/31/2025
- Amount recalled
- 165,678, 90-count bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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