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 059

FDA recall notice · announced August 9, 2017 · Teva Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/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
Quantity: 401,750 cartons
Status: Terminated
Products in this recall event:
- 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, C (D-1039-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.