FDAFDA · Food and drugs·Recall number D-0439-2017
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
Published February 1, 2017 · Recall initiated: January 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide in the US
- Lot
- Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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