Talon Compounding Pharmacy Injectable MIC B Complex Sterility Recall
Talon Compounding Pharmacy is recalling MIC B Complex with Chromium/Methylcobalamin injectable (Lot 09022021:50) 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable medication. The lack of assurance of sterility in an injectable product represents a direct risk of serious harm to patients, including infection and sepsis. Although no illnesses are reported in the source text, the hazard—non-sterile injectable—is inherent to the product category and poses significant risk without reported illness, meeting the High severity threshold.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B Complex with Chromium/Methylcobalamin injectable (4 vials, Lot 09022021:50, Beyond Use Date 12/01/2021) because there is a lack of assurance of sterility.
The product is a prescription injectable medication distributed across the United States, including Washington, D.C., and Puerto Rico. Compounded medications require confirmed sterility to ensure patient safety when administered.
Patients who have received this product should consult their healthcare provider. Healthcare providers who have dispensed this lot should immediately discontinue use and quarantine remaining units.
The recalled product
- Product
- MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 4
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: 09022021:50 BUD: 12/01/2021
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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