FDAFDA · Food and drugs·Recall number D-0922-2018
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
Published July 25, 2018 · Recall initiated: June 25, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- La Vita Compounding Pharmacy, LLC
- Distributor
- Product was distributed to patients via patient specific prescription only in CA.
- Lot
- Lot #: 140089@1, Exp 08/06/2018; 141968@6, Exp 09/03/2018; 143381@2, Exp 09/24/2018; 145265@13, Exp 10/22/2018; 146479@6, Exp 11/12/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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