Albuterol 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.
Reported: August 9, 2017 Initiated: July 25, 2017 #D-1039-2017
Product Description
Albuterol 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.
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 401,750 cartons
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Albuterol 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.. Recalled by Teva Pharmaceuticals USA. Units affected: 401,750 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Low. Recall number: D-1039-2017.
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