Class III · Lower riskRecall completed
Ipratropium Bromide And Albuterol Sulfate
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberMcKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
cGMP deviations: Temperature abuse
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byNephron Pharmaceuticals Corporation
| Brand name | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE |
| Generic name | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE |
| Active ingredient(s) | ALBUTEROL SULFATE, IPRATROPIUM BROMIDE |
| Distributed by / for | Mckesson Medical-Surgical Inc. Corporate Office |
| NDC | 0487-0201-03 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Distribution | USA nationwide. |
| Quantity | 56 pouches |
| Recall initiated | 2022-04-13 |
| Report date | 2022-06-15 |
| Recall completed | 2023-11-30 |
| Recall number | D-1021-2022 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Richmond VA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.