FDA recall D-1078-2015

Product

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.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2015-04-24

Report date

2015-05-20

Termination date

2017-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pithampur, District Dhar, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1078-2015