Glutathione Injectable Vials Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
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 a sterile injectable product with lack of assurance of sterility, creating risk of microbial contamination. No reported illnesses or hospitalizations are mentioned in the source, placing it in the High category per the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide throughout the United States and Puerto Rico.
The product is an injectable medication that must meet strict sterility standards. When the assurance of sterility cannot be guaranteed, there is a risk of microbial contamination that could lead to infection and other adverse health effects.
Healthcare providers and consumers who have received the recalled product should discontinue use immediately. Patients should contact their healthcare provider or the recalling firm for guidance regarding safe alternatives or replacement product.
The recalled product
- Product
- Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance
- 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 (18)
- Batch#: a) 01122204A1
- Exp 4/12/2022
- 02192214A1
- Exp 5/20/2022
- b) 12142122A2
- Exp. 3/14/2022
- 12282118A2
- Exp 3/28/2022
- 01112203A1
- Exp 4/11/2022
- 01122208A1
- 01202211A2
- Exp 4/20/2022
- 02032205A1
- Exp 5/4/2022
- 02192212A1
- 03042201A1
- Exp 6/2/2022.
Distribution
Distributed nationwide across the United States.
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