Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Reported: May 20, 2015 Initiated: April 24, 2015 #D-1078-2015
Product Description
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Reason for Recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Details
- Recalling Firm
- Cipla Limited
- Units Affected
- 140,625 Vials
- Distribution
- U.S. Nationwide including Puerto Rico.
- Location
- Pithampur, District Dhar, N/A
Frequently Asked Questions
What product was recalled? ▼
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.. Recalled by Cipla Limited. Units affected: 140,625 Vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2015. Severity: Low. Recall number: D-1078-2015.
Related Recalls
FDA Food Moderate
ALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA
INDIAN COOKWARE AND APPLIANCE LLC · 2026-01-07
FDA Drug Moderate
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersbu…
Acuity Specialty Products, Inc. · 2025-10-15
FDA Drug Moderate
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 De…
Acuity Specialty Products, Inc. · 2025-10-15
FDA Drug Low
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, …
Cipla USA, Inc. · 2025-08-27
CPSC Moderate
IKEA Recalls Garlic Presses Due to Laceration and Ingestion Hazards
IKEA US Retail LLC, of Woodbridge, Virginia · 2025-07-31