Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
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 with no reported illnesses or injuries. According to the severity rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High). The lack of sterility assurance in injectable pharmaceutical products represents a significant potential risk.
Plain-English summary
Tailor Made Compounding, operating as TMC Acquisition LLC, is recalling Vitamin B-Complex injectable vials due to lack of assurance of sterility. The recalled products were distributed nationwide in the USA and Puerto Rico.
The affected vials include 10 mL and 30 mL sizes with the following batch numbers and expiration dates: 10 mL vials (Batch 01252201A2, expires 3/26/2022); 30 mL vials (Batch 01252201A2 expires 3/26/2022, Batch 02032213A2 expires 4/4/2022, and Batch 03042209A1 expires 5/3/2022). A total of 75 vials are affected.
Consumers who have received these vials should stop using them and contact their healthcare provider. The company cannot assure the sterility of these injectable products, which is essential for safe intravenous or intramuscular use.
The recalled product
- Product
- Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable Vitamin
- Hazard
- lack-of-sterility
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 (7)
- Batch#: a) 01252201A2
- Exp 3/26/2022
- b) 01252201A2
- 02032213A2
- Exp 4/4/2022
- 03042209A1
- Exp 5/3/2022.
Distribution
Distributed nationwide across the United States.
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