5-Methyl Tetrahydrofolate 1 mg/ml Injectable recalled over sterility concerns
- Recall date
- June 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- The Compounding Pharmacy of America recalls 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Kn…
- Recall number
- D-1431-2015
- FDA classification
- Class II
- Brand / firm
- The Compounding Pharmacy of America
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
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