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
Reported: July 25, 2018 Initiated: June 25, 2018 #D-0922-2018
Product Description
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
Reason for Recall
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Details
- Recalling Firm
- La Vita Compounding Pharmacy, LLC
- Units Affected
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product 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. Recalled by La Vita Compounding Pharmacy, LLC. Units affected: 17,610 mL total dispensed in 10 mL and 30 mL vials.
Why was this product recalled? ▼
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0922-2018.
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