PlainRecalls
FDA Drug Low Class III Terminated

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1021-2022

Product Description

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
56 pouches
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 56 pouches.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Low. Recall number: D-1021-2022.