MethylPREDNISolone Acetate Injectable Suspension Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to temperature abuse during distribution. The drug was exposed to conditions that could affect its quality and safety.
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 an FDA Class II manufacturing defect affecting an injectable medication. It qualifies as a risk-of-harm product where no injury has been reported, which per the rubric scores as High (3).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling MethylPREDNISolone Acetate Injectable Suspension USP (400 mg/5 mL vials, NDC 16714-473-01) manufactured by NorthstarRx/Teva Pharma USA. The recall addresses current Good Manufacturing Practice (cGMP) deviations related to temperature abuse.
Temperature abuse during storage and distribution can affect the quality and safety of injectable medications. This recall applies to product distributed nationwide in the United States.
McKesson Medical-Surgical is unable to identify the specific lot numbers received by individual customers and has issued individual notification letters that specify the distribution dates of potentially affected product. Healthcare providers and pharmacies should review their notification letters to determine if they have received affected product.
Anyone in possession of this medication should contact their pharmacist or healthcare provider for guidance regarding their specific product.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-473-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Hazard
- temperature-abuse
- manufacturing-quality
Distribution
Distributed nationwide across the United States.
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