The Recall Desk
HighFDA (Drugs)·D-1062-2022·Announced 2022-06-15

FDA Recalls MethyLPREDNISolone Acetate Injectable Suspension Over Temperature Abuse

McKesson is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving temperature abuse.

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: FDA Class II classification with no reported illnesses or injuries. This represents a risk-of-harm product where injury has not been reported, consistent with High severity per the rubric.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL) manufactured by Northstar Rx/Teva Pharma USA. This product has been distributed nationwide.

The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. McKesson is unable to identify the specific lot numbers received by individual customers but has provided distribution timeline information to customers.

Healthcare providers and pharmacies who received this product should contact McKesson or their supplier for additional information and instructions.

The recalled product

Product
MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable Corticosteroid
Hazard
  • temperature-abuse

Distribution

Distributed nationwide across the United States.

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