Agency classClass IIOur severity:High FDA (Drugs)·D-1070-2022·Announced 2022-06-15

Methylprednisolone Acetate Injectable Suspension Recalled for Manufacturing Temperature Deviations

McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.

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 drug recall with manufacturing defects (temperature control violations) that may affect drug quality and potency. No illnesses or adverse events are reported, but the potential for harm exists per the agency's classification, meeting the rubric criterion for risk-of-harm products.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Methylprednisolone Acetate Injectable Suspension, USP, 40 mg/mL nationwide. The recall includes 983 cartons of single-dose vials (NDC 0703-0031-01) and 107 cartons of 25-vial boxes (NDC 0703-0031-04), manufactured by Teva Pharma USA.

The recall is due to deviations from current Good Manufacturing Practice (cGMP) standards. Temperature abuse occurred during manufacturing, which may compromise the quality and potency of the medication.

This prescription injectable suspension is distributed to healthcare providers, hospitals, and pharmacies throughout the United States. Healthcare facilities should cease dispensing affected product and contact McKesson for return instructions and lot number information.

Patients or healthcare providers with questions should review the distribution dates in McKesson's correspondence, as specific lot numbers could not be retrospectively identified.

The recalled product

Product: MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Category: Drug — Prescription Injectable
Hazard: temperature-abuse
manufacturing-defect

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.

See all 130 products in this recall →

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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