D-1039-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2017
- Initiation Date
- July 25, 2017
- Termination Date
- April 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 401,750 cartons
Product Description
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #s: GA60206, GA60207, Exp 08/17; GA60283, GA60284, Exp 09/17; GA60378, GA60379, GA60478, Exp 10/17; GA60491, Exp 11/17; GA60615, GA60616, Exp 12/17; GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, Exp 01/18; GA70001, GA70031, GA70046, GA70047, GA70074, GA70075, Exp 06/18