Methylprednisolone Acetate Injectable Suspension Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature abuse during manufacturing that may affect product quality. Healthcare providers should verify receipt.
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 FDA Class II recall addresses a manufacturing process deviation (temperature abuse) affecting injectable medication with nationwide distribution. Although no illnesses or injuries have been reported, injectable drugs with temperature-related process deviations pose a risk to product sterility and efficacy.
Plain-English summary
McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, manufactured by Teva Pharma USA. The product is available in single-dose vials (NDC 0703-0051-01) and 25-count boxes (NDC 0703-0051-04).
The recall is due to cGMP deviations involving temperature abuse during manufacturing, which may affect product quality, potency, or integrity.
The product was distributed nationwide to healthcare facilities. Affected quantities include 1088 cartons of single-dose vials and 63 cartons of 25-vial boxes. Specific lot numbers have not been identified; McKesson has sent notification letters to affected customers with their specific shipment dates and dates of potentially impacted product.
Healthcare providers who received this product should verify receipt and consult with McKesson regarding appropriate measures. As of the recall notification, no illnesses or injuries have been reported associated with this product.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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