Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL sterile unit-dose vials. The recall affects one carton containing 30 pouches that were distributed nationwide in the USA. The product was manufactured by Nephron Pharma. The recall was initiated due to temperature abuse that violated good manufacturing practices (cGMP) standards.
Because McKesson Medical-Surgical is unable to identify which specific lot numbers were received by individual customers, the company has provided each customer with the distribution date and the dates that potentially affected product may have been shipped to them. The record does not specify a remedy or required action for consumers.
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: 1 carton/30 pouches each 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.