Agency classClass IIOur severity:High FDA (Drugs)·D-1211-2022·Announced 2022-07-20

Levocarnitine Injection Recalled Due to Lack of Sterility Assurance

Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.

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 a Class II FDA recall for an injectable pharmaceutical with lack of sterility assurance. No illnesses or hospitalizations have been reported. The hazard is theoretical but constitutes a risk-of-harm product per the rubric, warranting a High severity score.

Plain-English summary

Tailor Made Compounding is recalling Levocarnitine 500mg/mL injection vials distributed nationwide in the USA and Puerto Rico due to lack of assurance of sterility. The FDA classified this as a Class II recall.

The affected batches are: Batch #12022124A2 (expiration date 3/2/2022) and Batch #03032223A1 (expiration date 6/1/2022). A total of 12 vials were recalled.

Patients and healthcare providers who have these specific batches should not use the product and should contact their healthcare provider for guidance on any doses that may have been administered.

The recalled product

Product: Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Injectable Pharmaceutical
Hazard: lack-of-sterility
contamination-risk
Affected units: 12

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 #: 12022124A2
Exp 3/2/2022
03032223A1
Exp 6/1/2022.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

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Same hazard · lack of sterility