FDA Recalls NDC 0591-3467 Albuterol Sulfate
Solution Intrabronchial

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Albuterol Sulfate with NDC 0591-3467 was initiated on 07-25-2017 as a Class III recall due to failed impurities/degradation specifications: high out of specification results for related compound d. The latest recall number for this product is D-1039-2017 and the recall is currently terminated as of 04-26-2018 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1039-201707-25-201708-09-2017Class III401,750 cartonsAlbuterol 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.Terminated
D-0439-201701-12-201702-01-2017Class III164,844 unitsAlbuterol 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 0591-3467-53Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.