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.
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 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
- Affected units
- 40
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
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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