United StatesDuloxetine Delayed-Release Capsules USP, 60 mg, 90‑count bottles (NDC 51991-748-90), Lot 241069C, exp 05/31/2027, manufactured by Towa Pharmaceutical Europe S.L. and distributed by Breckenridge Pharmaceutical, Inc. are affected. They were recalled due to current good manufacturing practice (CGMP) deviations and the presence of N-nitroso-duloxetine impurity above the FDA recommended limit.
What's being recalled
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States.
How to identify it
Lot: 241069C, Exp 05/31/2027
The hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)