Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-
Summary
The FDA issued a Class III for Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vi by Mckesson Medical-Surgical Inc. Corporate Office. Reason: cGMP deviations: Temperature abuse.
Details
Source
Drug Recall
External ID
D-1021-2022
Action Date
2022-06-15
Status
Terminated
Category
drug
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
Lot/Code Info: McKesson 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.
Quantity Affected: 56 pouches
Reason for Recall
cGMP deviations: Temperature abuse
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-13
Company
Richmond, VA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 180 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1021-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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