SUN PHARMACEUTICAL INDUSTRIES INC — Class II: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single
Sun Pharmaceutical Industries Inc. has initiated a Class II recall for Budesonide Inhalation Suspension (1mg/2mL) due to reports of black and brown specks and particles found within sterile single-dose ampules.
This recall affects Sun Pharmaceutical Industries Inc., distributors, healthcare providers, and pharmacy departments responsible for handling NDC 47335-633-49. Operations at the manufacturing site in Gujarat, India, are also implicated.
The presence of foreign substances in a sterile inhalation solution represents a significant quality failure. For inhalation products, particulate matter poses potential safety risks to the respiratory tract, suggesting a lapse in contamination control or primary packaging integrity. This ongoing recall indicates that existing quality control measures may not have identified these contaminants prior to distribution.
Quality teams should immediately verify if affected lots are in inventory and begin quarantine procedures. Manufacturing and QA should initiate a root cause investigation into the source of the foreign particles, potentially focusing on the ampule filling and sterilization processes. Review of complaint logs for similar particulate reports is advised.
Class II. Reason: 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. Product: 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.. Firm: SUN PHARMACEUTICAL INDUSTRIES INC (Princeton NJ United States). Status: Ongoing.
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