Biotin 5mg/mL injection recalled for lack of sterility assurance
Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.
What this means for you
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: FDA Class II recall of an injectable product with unassured sterility. This represents a risk-of-harm product where no illnesses have been reported. The hazard stems from the manufacturer's inability to demonstrate proper sterilization.
Plain-English summary
Tailor Made Compounding is recalling Biotin 5mg/mL injectable solutions distributed nationwide and in Puerto Rico. The recall was initiated because the manufacturer cannot provide assurance that the product was sterilized according to FDA-approved methods.
The affected product is a 5mL vial of Biotin at a concentration of 5mg/mL intended for injection and requiring refrigeration. Two batches are involved in this recall: Batch #12032113A2 (expiration 6/1/2022) and Batch #01102206A1 (expiration 7/9/2022). A total of 39 vials were distributed.
Consumers and healthcare providers who have the affected product should stop using it immediately and contact Tailor Made Compounding or the FDA for instructions on returning or disposing of the vials. Unsterilized injectable products could pose a risk of serious infection.
The recalled product
- Product
- Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Hazard
- lack-of-sterility
- infection-risk
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 (4)
- Batch #: 12032113A2
- Exp 6/1/2022
- 01102206A1
- Exp 7/9/2022.
Distribution
Distributed nationwide across the United States.
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