The Recall Desk
HighFDA (Drugs)·D-1205-2022·Announced 2022-07-20

Glutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues

Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials 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 sterility assurance issues, presenting a risk of infection. No illnesses or injuries have been reported in the source text, so the score is 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Tailor Made Compounding (TMC Acquisition LLC) is recalling Glutathione 200mg/mL Preservative Free Injectable, 30mL vials due to lack of assurance of sterility. The recall affects 40 vials distributed nationwide in the USA and Puerto Rico.

The FDA classified this as a Class II recall. The affected batches are: Batch #12062113A2 (expiration date 3/6/2022), Batch #01052209B (expiration date 4/5/2022), and Batch #01312223A1 (expiration date 5/1/2022).

The recalled product

Product
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Compounded Injectable
Hazard
  • lack-of-sterility
  • infection-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 (6)

  • Batch #: 12062113A2
  • Exp 3/6/2022
  • 01052209B
  • Exp 4/5/2022
  • 01312223A1
  • Exp 5/1/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

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