D-0439-2017 Class III Terminated
FDA drug recall D-0439-2017 was initiated by Actavis Inc on Jan 12, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. The recall status is terminated (terminated Mar 5, 2018). Affected quantity: 164,844 units.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 1, 2017
- Initiation Date
- Jan 12, 2017
- Termination Date
- Mar 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164,844 units
Product description
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
Reason for recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Distribution pattern
Nationwide in the US
Code information
Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0439-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026