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.
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 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
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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