Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.
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: This is an FDA Class II recall involving a documented failure to assure sterility of an injectable medication. While no illnesses or injuries have been reported, the product poses an inherent contamination risk, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling Vitamin B-Complex Preservative Free 3ml vials because of lack of assurance of sterility. The recalled batch is number 03112233B with expiration date 5/10/2022. The product was distributed nationwide in the USA and Puerto Rico in packages of 6 vials.
The FDA classified this as a Class II recall. The manufacturer failed to provide assurance that the affected batch met required sterility standards.
Consumers and healthcare providers should not use this product. Unused product should be destroyed or returned to the manufacturer.
The recalled product
- Product
- Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- 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)
- Batch#: 03112233B
- Exp 5/10/2022
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding 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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