MIC B12 and L-Carnitine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B12 25/50/50/0.5MG/ML L-Carnitine 250MG/ML Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
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 of a compounded injectable product with a sterility defect. Injectable products that lack sterility assurance pose a risk of serious infection and potentially require hospitalization. Per the rubric, FDA Class II recalls with risk of serious injury are classified as Severe.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling MIC B12 25/50/50/0.5MG/ML L-Carnitine 250MG/ML Injectable (Rx only) due to lack of assurance of sterility. This is a compounded injectable product.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The recalled lot is Lot 07272021:62 with a Beyond Use Date (BUD) of 10/25/2021.
Consumers and healthcare providers in possession of this product should stop using it immediately and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy for instructions on how to return or dispose of the product. Patients who have received injections of this product should consult their healthcare provider if they have any health concerns.
The recalled product
- Product
- MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML 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: 07272021:62 BUD: 10/25/2021
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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