HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling HydrOXYzine Pamoate Capsules, USP, 50 mg in 100-count bottles manufactured by Sandoz Pharma due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. The affected product was distributed nationwide, with 30 bottles totaling 3,000 capsules involved in the recall. Because specific lot numbers cannot be identified for individual customers, affected consumers will receive letters indicating the dates their product may have been shipped.
The recall source does not specify a remedy or recommended action for consumers who have received this product.
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: 30 bottles/100 capsules per bottle 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.