Injectable Pantoprazole Sodium Recalled for Temperature Exposure During Manufacturing
McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm injectable product affected by manufacturing defects (temperature abuse during production) that could impact drug stability and efficacy. No illnesses or injuries have been reported. This aligns with the High severity criterion for risk-of-harm products without documented injury.
Plain-English summary
Pantoprazole Sodium for Injection, 40 mg/vial (10 single-dose vials per carton), manufactured by Sandoz Pharma and distributed by McKesson Medical-Surgical Inc., is being recalled nationwide. The product is a prescription injection used for certain gastrointestinal conditions.
The recall is due to current Good Manufacturing Practice (cGMP) deviations during manufacturing, specifically temperature abuse of the product. Temperature exposure may compromise the drug's stability, potency, or safety. McKesson is unable to identify which specific lot numbers were received by individual customers and has provided distribution and shipment dates for potentially affected product.
The product was distributed throughout the United States. Healthcare facilities and individuals who obtained this product should verify receipt using the distribution and shipment dates provided in the recall notice. Those with the product should discontinue use and contact their healthcare provider or McKesson for further guidance.
The recalled product
- Product
- Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable / Injection
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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