FDA Recalls Metoprolol Tablets Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.
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 recall for manufacturing quality deviation. No illnesses or injuries reported. Temperature abuse affecting pharmaceutical stability represents a potential risk-of-harm to medication efficacy and patient safety without documented patient harm, meeting the High severity criterion.
Plain-English summary
Metoprolol tablets 50 mg (100-count bottles, NDC 57664-0477-52) distributed by McKesson Medical-Surgical Inc. are being recalled nationwide. The recall is due to current good manufacturing practice (cGMP) deviations, specifically temperature abuse during manufacturing or storage that may affect the stability of the medication.
This recall affects Metoprolol prescriptions distributed to patients across the United States. Patients currently taking this medication should contact their pharmacy or prescribing physician immediately to determine whether their supply is affected and to discuss whether alternative medication is needed.
McKesson Medical-Surgical states it is unable to identify specific lot numbers for all affected consignees. Distribution letters containing the dates affected product may have been shipped have been sent to customers.
The recalled product
- Product
- Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- cgmp-deviation
Distribution
Distributed nationwide across the United States.
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