Reported Apr 30, 2025 · Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical…
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, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
- Lot codes and dates
Lot # 240987Cexp. date 04/2027 241014Cexp. date 04/2027
- Amount recalled
- 16,473 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
This product could cause temporary or reversible health problems — stop using it.
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