MethylPREDNISolone Acetate Injectable Suspension Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to cGMP deviations involving temperature abuse during manufacturing. Affected vials were distributed nationwide.
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 for a sterile injectable pharmaceutical affected by temperature abuse during manufacturing. No illnesses or injuries have been reported; however, temperature deviations can compromise the sterility and potency of injectable suspensions, representing a risk of harm to patients who may receive affected doses.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling MethylPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), in 5 mL multi-dose vials. This prescription corticosteroid injection is manufactured by Teva Pharma USA (NDC 0703-0063-01). The recall affects 816 cartons, each containing one vial, and the product was distributed nationwide in the United States.
The recall was initiated due to cGMP deviations involving temperature abuse during manufacturing. Temperature control is essential for maintaining the sterility, potency, and safety of injectable pharmaceutical suspensions.
Healthcare providers and patients who have received this product should discontinue use immediately and contact their pharmacy or healthcare provider. McKesson Medical-Surgical notified its customers about the affected product with letters specifying distribution dates and shipment timeframes, since specific lot numbers could not be identified for all consignees.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
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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