FDA recall D-1021-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class III · drug
Product
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
Distribution
USA nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-13
- Report date
- 2022-06-15
- Termination date
- 2023-11-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1021-2022