FDAClass IIIJune 15, 2022

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recall: CGMP Deviations

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

Why was Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalled?

cGMP deviations: Temperature abuse

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
56 pouches
Distribution
USA nationwide.
Recall date
June 15, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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