Methylprednisolone Acetate Injectable Suspension Recalled for Manufacturing Temperature Deviations
McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.
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: FDA Class II drug recall with manufacturing defects (temperature control violations) that may affect drug quality and potency. No illnesses or adverse events are reported, but the potential for harm exists per the agency's classification, meeting the rubric criterion for risk-of-harm products.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Methylprednisolone Acetate Injectable Suspension, USP, 40 mg/mL nationwide. The recall includes 983 cartons of single-dose vials (NDC 0703-0031-01) and 107 cartons of 25-vial boxes (NDC 0703-0031-04), manufactured by Teva Pharma USA.
The recall is due to deviations from current Good Manufacturing Practice (cGMP) standards. Temperature abuse occurred during manufacturing, which may compromise the quality and potency of the medication.
This prescription injectable suspension is distributed to healthcare providers, hospitals, and pharmacies throughout the United States. Healthcare facilities should cease dispensing affected product and contact McKesson for return instructions and lot number information.
Patients or healthcare providers with questions should review the distribution dates in McKesson's correspondence, as specific lot numbers could not be retrospectively identified.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Injectable
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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