The Recall Desk
HighFDA (Drugs)·D-1206-2022·Announced 2022-07-20

Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance

Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.

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: FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable preparation—is a theoretical contamination risk. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Tailor Made Compounding is recalling its Glycyrrhizic Acid 8mg/mL injectable solution (10mL vials) distributed nationwide and in Puerto Rico. The recall affects 101 vials from two batches: lot #12172114A2 (expiration 3/17/2022) and lot #01142211A1 (expiration 4/14/2022). The reason for the recall is lack of assurance of sterility.

This is a compounded pharmaceutical preparation intended for injection. A sterile injectable preparation that does not meet sterility standards poses a risk of infection to patients who receive it.

If you have received this product, contact your healthcare provider immediately. Do not use any remaining vials. For additional information, contact the FDA or Tailor Made Compounding.

The recalled product

Product
Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
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 #: 12172114A2
  • Exp 3/17/2022
  • 01142211A1
  • Exp 4/14/2022.

Distribution

Distributed nationwide across the United States.