The Recall Desk
HighFDA (Drugs)·D-1061-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • potency-loss

Distribution

Distributed nationwide across the United States.

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