Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Ondansetron HCL 8 mg film-coated tablets in 30-count bottles distributed nationwide in the United States. The recall affects approximately 2 bottles containing 500 tablets each and was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during storage or handling. The product is a prescription medication manufactured by Sandoz Pharma.
McKesson Medical-Surgical was unable to identify the specific lot numbers received by individual customers, but provided distribution dates in recall letters to help affected consignees determine if they received impacted product based on the dates their shipments were sent. The recall notice 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: 2 bottles/500 tablets 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.