FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.
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 medication with a potential sterility defect. While the product presents a risk of contamination for injectable use, the source does not report any confirmed adverse events, illnesses, or injuries, limiting the score to High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL injectable solution. The recall affects product distributed nationwide in the USA and Puerto Rico. The manufacturer cannot assure that the product meets required sterility standards for injectable medications.
The affected batches include: Batch #10122110A2 (expiration 3/20/2022), Batch #12062110A2 (expiration 4/30/2022), and Batches #02012202A2 and #02192207A1 (expiration 7/31/2022). The product is supplied in 30mL vials that require refrigeration.
Anyone with affected vials should contact the manufacturer or FDA. Tailor Made Compounding is the recalling firm.
The recalled product
- Product
- GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- contamination
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 (7)
- Batch #: 10122110A2
- Exp 3/20/2022
- 12062110A2
- Exp 4/30/2022
- 02012202A2
- 02192207A1
- Exp 7/31/2022.
Distribution
Distributed nationwide across the United States.
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