METHYLCOBALAMIN/FOLIC ACID recalled over sterility concerns
- Recall date
- May 17, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Well Care Compounding Pharmacy recalls METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las V…
- Recall number
- D-1002-2016
- FDA classification
- Class II
- Brand / firm
- Well Care Compounding Pharmacy
- Sold / distributed
- NV
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
METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
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