La Vita Compounding Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns
La Vita Compounding Pharmacy is recalling Methylcobalamin 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 agency classification is FDA Class II, and the hazard involves a lack of processing controls that questions the sterility of an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
La Vita Compounding Pharmacy, LLC is recalling Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water) packaged in 10 mL and 30 mL vials. The recall was initiated because the products were produced in a manner that calls into question the sterility of the drug product intended to be sterile.
The affected product is prescription-only and was distributed to patients via patient-specific prescriptions in California. A total of 19,040 mL was dispensed across the affected lots, which include expiration dates ranging from July 2018 to November 2018.
Patients who have received this medication should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 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 (12)
- Lot #s: 139140@3
- Exp 07/23/2018
- 141106@1
- Exp 08/21/2018
- 142919@13
- Exp 09/17/2018
- 143291@6
- Exp 09/23/2018
- 145701@3
- Exp 10/29/2018
- 146932@3
- Exp 11/19/2018
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.
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