La Vita Compounding Pharmacy, LLC recalls Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VIT…
- Recall date
- June 25, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0922-2018
- FDA classification
- Class II
- Brand / firm
- La Vita Compounding Pharmacy, LLC
- Sold / distributed
- Product was distributed to patients via patient specific prescription only in CA.
Why it was recalled
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
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