Drug 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
D-0439-2017
Product summary
- Firm
- Actavis Inc
- Event
- Event 76229
- Status
- Terminated
- Classification
- Class III
- Quantity
- 164,844 units
- Official record key
drug-enforcement:D-0439-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Code information: Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
out of specification