Injectable MethyLPREDNISolone Suspension Recalled Due to Temperature Abuse
MethyLPREDNISolone Acetate Injectable Suspension (400 mg/10 mL) is recalled due to temperature abuse during storage that may have compromised product quality. Approximately 796 vials were 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: FDA Class II classification for a sterile injectable with manufacturing process deviations involving temperature abuse. No illnesses or injuries have been reported. This represents a risk-of-harm product where potential injury has not yet been reported, fitting Score 3 criteria.
Plain-English summary
MethyLPREDNISolone Acetate Injectable Suspension USP (400 mg/10 mL, 40 mg/mL) in 10 mL multi-dose vials manufactured by Teva Pharma USA has been recalled. The product is distributed by Mckesson Medical-Surgical Inc.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. Exposure to improper temperatures during storage may have affected the product's stability and quality.
Approximately 796 cartons (one vial each) were distributed nationwide across the United States. The manufacturer was unable to identify specific lot numbers for each customer; customers were notified with shipment dates to help identify affected inventory.
Patients and healthcare providers should stop using affected vials and consult with their healthcare provider regarding alternative treatments. Pharmacies and healthcare facilities should verify their inventory against notification letters that included shipment dates.
The recalled product
- Product
- MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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