Recalls / Class III
Class IIID-0439-2017
Product
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
- Affected lot / code info
- Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 164,844 units
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-01-12
- FDA classified
- 2017-01-24
- Posted by FDA
- 2017-02-01
- Terminated
- 2018-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0439-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.