MIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.
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 an injectable medication with a theoretical hazard (lack of assurance of sterility) and no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Carolina Infusion LLC is recalling MIC/B12 25/50/50/1 MG/ML Injectable vials in the 10 ML size due to lack of assurance of sterility.
The recalled product lots are 08012022@4 and 08082022@12, with beyond-use dates of 01/28/2023 and 02/04/2023 respectively. These vials were distributed nationwide in the United States.
Patients who received these vials should consult with their healthcare provider about the recall. The lack of sterility assurance means the product may not meet required safety standards for injectable medications.
Consumers should not use recalled vials and should return them to their pharmacy or healthcare provider.
The recalled product
- Product
- MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 3
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)
- Lots: 08012022@4 BUD: 01/28/2023
- 08082022@12 BUD: 02/04/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Carolina Infusion 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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