Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Prednisolone Acetate Ophthalmic Suspension, USP 1% in 5 mL bottles manufactured by Sandoz Pharma due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. The recall affects 50 bottles distributed nationwide across the United States. Because McKesson cannot identify which specific lot numbers were received by individual customers, recall letters include the distribution date to each customer and the date range when affected product may have been shipped to them.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
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: 50 bottles 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.