FDA Recalls MethyLPREDNISolone Acetate Injectable Suspension Over Temperature Abuse
McKesson is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving temperature abuse.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 classification with no reported illnesses or injuries. This represents a risk-of-harm product where injury has not been reported, consistent with High severity per the rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL) manufactured by Northstar Rx/Teva Pharma USA. This product has been distributed nationwide.
The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. McKesson is unable to identify the specific lot numbers received by individual customers but has provided distribution timeline information to customers.
Healthcare providers and pharmacies who received this product should contact McKesson or their supplier for additional information and instructions.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Hazard
- Affected units
- 263
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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