Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Ipratropium Bromide Inhalation Solution (0.02%, 0.5 mg/2.5 mL) distributed nationwide in the United States due to temperature abuse during storage or handling. The product is a prescription-only medication packaged in boxes containing 25 sterile unit-dose vials. A total of 57 pouches were affected by this recall.
The temperature abuse represents a deviation from good manufacturing practices (cGMP) that could potentially compromise the quality or safety of the medication. McKesson was unable to identify the specific lot numbers received by individual customers, but provided distribution dates and potential shipping dates with recall notifications to help identify affected product. The source does not specify what action affected consumers should take regarding recalled product in their possession.
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: 57 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.