United StatesBudesonide Inhalation Suspension 1 mg/2 mL in cartons of 30 sterile single‑dose 2 mL ampules (NDC 47335‑633‑49), Lot BAG0074A, Exp. 1/31/2027, distributed by Sun Pharmaceutical Industries Inc. is being recalled. The recall was issued because black/brown specs and particles were reported in the ampoule solution.
What's being recalled
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Recalling firm: Sun Pharmaceutical Industries Inc, Princeton, NJ, United States.
How to identify it
Lot #: BAG0074A, Exp. Date: 1/31/2027.
The hazard
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
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 within the United States
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)