Methyl Folate CA+ 1mg/ml Injection w/Pres recall: Sterility Concern
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…
Why was Methyl Folate CA+ 1mg/ml Injection w/Pres recalled?
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- La Vita Compounding Pharmacy, LLC
- Quantity
- 17,610 mL total dispensed in 10 mL and 30 mL vials
- Distribution
- Product was distributed to patients via patient specific prescription only in CA.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)