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
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution in 3mL vials due to temperature abuse during storage, which violates good manufacturing practice standards. The affected products are available in 30-count packaging (NDC 0487-0201-03) and 60-count packaging (NDC 0487-0), and the recall affects 56 pouches distributed nationwide throughout the United States.
McKesson Medical-Surgical was unable to identify the specific lot numbers received by individual customers, so the company provided distribution dates and shipping date ranges in letters to affected customers to help identify potentially impacted product. The source document does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 56 pouches 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.