MethyLPREDNISolone Acetate Suspension Recalled for Temperature Abuse
Mckesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature-abuse cGMP deviations affecting 363 vials distributed nationwide.
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 recall for cGMP deviations involving temperature abuse of a prescription corticosteroid. No illnesses, adverse events, or injuries reported. Per the rubric, theoretical hazards without reported harm are scored at most 3.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL vials (NDC 16714-090-01, manufactured by NorthstarRx/Teva Pharma USA) due to cGMP deviations involving temperature abuse. A total of 363 vials have been recalled.
The recalled product was distributed nationwide in the United States. Temperature abuse during storage or distribution may compromise product quality, stability, or sterility. No adverse events, illnesses, or injuries have been reported in connection with this recall.
Healthcare facilities and pharmacies that received affected vials should immediately cease use and contact Mckesson Medical-Surgical for product identification and return instructions. Because product lot numbers cannot be definitively identified by the distributor, the recall includes all potentially affected inventory from the specified distribution period.
Patients currently receiving this medication should not discontinue treatment without consulting their healthcare provider. Healthcare providers can contact the FDA or Mckesson Medical-Surgical for additional information regarding this recall.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-090-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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