United StatesCarbidopa, Levodopa, Entacapone tablets, 25 mg/100 mg/200 mg in 100-count bottles (NDC 16571-691-01), lot CS25070, exp. 03/31/2027, manufactured for Rising Pharma Holding, Inc., distributed nationwide in the U.S. are affected. They were recalled after a complaint that sealed bottles labeled as the 25/100/200 mg strength contained higher-strength tablets (37.5 mg/150 mg/200 mg) due to a product mix-up.
What's being recalled
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
Recalling firm: Rising Pharma Holding, Inc., East Brunswick, NJ, United States.
How to identify it
Lot # CS25070, exp. date 03/31/2027
The hazard
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
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
Distributed 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)