The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1071-2022·Announced 2022-06-15

MethyLPREDNISolone Acetate Injectable Suspension Recall Due to Temperature Abuse

McKesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature abuse during storage that may compromise sterility and efficacy. The recall affects 65 vials 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 of an injectable product where temperature abuse has compromised manufacturing standards. While no illnesses or injuries have been reported, the hazard presents a risk of harm—compromised sterility or efficacy in a multi-dose injectable medication—fitting the rubric criterion for Score 3.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling MethyLPREDNISolone Acetate Injectable Suspension, USP (40 mg/mL, 5 mL multi-dose vials, manufactured by Teva Pharma USA), NDC 0703-0043-01. The recall involves 65 cartons, each containing one vial.

The product was subject to temperature abuse that constitutes a deviation from current good manufacturing practice (cGMP) standards. Temperature excursions during storage or transport can compromise the stability and sterility of injectable medications, potentially affecting product safety and efficacy.

The affected product was distributed nationwide in the United States. McKesson states that it cannot identify the specific lot numbers received by individual customers; however, notification letters have been sent to all affected consignees with details of the dates when impacted product may have been shipped to them.

Healthcare providers and patients who have received this product should contact their pharmacy or McKesson for specific lot information and guidance. Clinicians should assess whether affected product may have been administered and take appropriate clinical actions.

The recalled product

Product
MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0043-01
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable / Corticosteroid
Hazard

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 →

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