Recalls / Class III
Class IIID-1039-2017
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.
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 401,750 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-07-25
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2018-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1039-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.