MIC B12 Compounded Injectable Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a lot of MIC B12 25/50/50/1+B6 injectable because the manufacturer cannot assure sterility of the 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: This is an FDA Class II recall involving a sterile injectable drug product where sterility cannot be assured. Such products pose a direct risk of serious infection if administered to patients, and the sterility hazard in injectable drugs meets the Severe threshold per the rubric criteria for Class II recalls with significant risk of harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling lot 08112021:23 of MIC B12 25/50/50/1+B6 100 MG/ML injectable (with best-use date of 11/09/2021) distributed throughout the United States, including Washington, D.C. and Puerto Rico.
The recall was initiated due to lack of assurance of sterility. Injectable products require strict sterility standards to prevent infection and other serious health complications when administered to patients.
Patients who have received this product should consult their healthcare provider immediately if they experience any signs of infection or adverse health effects. Healthcare providers and patients in possession of this medication should stop using it and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy for further guidance.
The recalled product
- Product
- MIC B12 25/50/50/1+B6 100 MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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 (1)
- Lot: 08112021:23 BUD: 11/09/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy 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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