MIC B Complex Injectable Compounded Drug Recall for Sterility Assurance
Talon Compounding Pharmacy is recalling MIC B Complex with Hydroxocobalamin 5MG/ML injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.
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 drug involving lack of sterility assurance. Per the severity rubric, FDA Class II recalls are classified as Severe (score 4) when they involve injectable products where sterility cannot be assured, presenting risk of serious infection.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B Complex with Hydroxocobalamin 5MG/ML Injectable due to lack of assurance of sterility. The product is a prescription injectable compounded drug supplied in 6-vial containers.
The affected lot numbers are 07152021:91 (Best Use Date 10/13/2021) and 08202021:06 (Best Use Date 11/18/2021). Distribution includes the United States, Washington, D.C., and Puerto Rico.
Consumers who have received this product should contact their healthcare provider immediately. Patients should not use the recalled vials and should consult with their physician regarding alternative treatment options.
The recall was issued by the FDA as a Class II recall and is identified by recall number D-0131-2022.
The recalled product
- Product
- MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 6
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 (2)
- Lot: 07152021:91 BUD: 10/13/2021
- 08202021:06 BUD: 11/18/2021
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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