FDA Recalls Methylprednisolone Acetate Injection for Temperature Abuse During Distribution
McKesson Medical-Surgical is recalling 885 vials of Methylprednisolone Acetate Injectable Suspension USP (40 mg/mL) due to cGMP deviations from temperature abuse. The product was distributed nationwide, but specific lot numbers could not be identified by the distributor.
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: This is an FDA Class II recall of an injectable corticosteroid due to cGMP deviations from temperature abuse. Temperature-compromised injectable medications represent a risk of harm (potential loss of potency or efficacy), but no illnesses, injuries, or deaths have been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling 885 vials of Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL. The product is being recalled due to cGMP deviations associated with temperature abuse during distribution. The recalled product includes both single-dose vials (NDC 6714-088-01) and 25-count boxes (NDC 16714-088-25) manufactured by Northstar Rx/Teva Pharma USA.
The recalled product was distributed nationwide. McKesson Medical-Surgical has notified affected customers about the recall. The company was unable to identify specific lot numbers that may have been received by particular customers, as this information varies by consignee. Each notification letter to customers included the distribution date and the date range during which the impacted product may have been shipped.
Methylprednisolone Acetate Injectable Suspension is a corticosteroid medication used for various therapeutic purposes. Temperature abuse during distribution can affect the quality and integrity of the product. Healthcare providers, pharmacists, and patients who may have received this product should consult with their healthcare provider if they have questions about their specific product lot.
Patients should not discontinue use of their medication without consulting their healthcare provider. Individuals who believe they have received a recalled lot should speak with their pharmacist or healthcare provider about next steps.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Affected units
- 885
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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