The Recall Desk
HighFDA (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.

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 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

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.

Related recalls

Same category