La Vita Compounding Pharmacy Recalls Methyl Folate Injection Due to Sterility Concerns
La Vita Compounding Pharmacy is recalling Methyl Folate CA+ 1mg/ml Injection vials because production methods raised questions about the sterility of the drug product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the snippet, the agency classification and the nature of the sterility defect in an injectable drug place it in the Severe category.
Plain-English summary
La Vita Compounding Pharmacy, LLC is recalling Methyl Folate CA+ 1mg/ml Injection vials (10 mL and 30 mL) containing Benzyl Alcohol 1% in Sterile Water. The recall was initiated due to a lack of processing controls, which resulted in products being produced in a manner that calls into question the sterility of the drug product intended to be sterile.
The affected product was distributed to patients via patient-specific prescription only in California. A total of 17,610 mL was dispensed in 10 mL and 30 mL vials. The specific lots involved are 140089@1 (Exp 08/06/2018), 141968@6 (Exp 09/03/2018), 143381@2 (Exp 09/24/2018), 145265@13 (Exp 10/22/2018), and 146479@6 (Exp 11/12/2018).
Patients who received this medication should contact their healthcare provider or La Vita Compounding Pharmacy at 858.453.2500 for further instructions.
The recalled product
- 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, 858.453.2500
- Manufacturer
- La Vita Compounding Pharmacy, LLC
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by La Vita Compounding Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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