Reported May 15, 2024 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count…
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, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist
- byBreckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922
- Lot codes and dates
- 220265: Exp
- Feb 2025 220088Exp
- Nov 2024 220267Exp
- Feb 2025 220256Exp
- Feb 2025 220225Exp
- Jan 2025 220269Exp. Feb 2025
- Amount recalled
- 281,554/90 & 1000 count bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
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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