Compounded injectable product recalled for lack of sterility assurance
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
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 of an injectable product with lack of sterility assurance, representing a risk-of-harm scenario where injury has not yet been reported. The source text does not report any illnesses or hospitalizations.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 25 vials of a compounded injectable product containing inositol, choline, B12, and carnitine. The recalled batches are: Batch 01212203A2 (expires 4/21/2022) and Batch 02232213A1 (expires 5/24/2022).
The product is being recalled due to lack of assurance of sterility. This means the manufacturer cannot confirm the product is free from contamination before reaching patients.
The affected product was distributed nationwide in the USA and Puerto Rico.
Those in possession of the recalled batches should not use the product and should contact Tailor Made Compounding for guidance.
The recalled product
- Product
- Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Affected units
- 25
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#: 01212203A2
- Exp 4/21/2022
- 02232213A1
- Exp 5/24/2022.
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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