Compounded Injectable Amino Acid Drug Recalled for Sterility Assurance Issues
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
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 for lack of sterility assurance in an injectable drug product. No illnesses or injuries have been reported. The score of 3 (High) reflects that this is a risk-of-harm product (a parenteral preparation without assured sterility) where no actual injury has been documented, per the rubric criteria.
Plain-English summary
Tailor Made Compounding is recalling GOAL injectable vials nationwide. GOAL is a compounded preparation containing Glutamine, Ornithine, Arginine, and Lysine in 30-milliliter vials.
The recall is due to lack of assurance of sterility. Injectable preparations require strict sterility to prevent contamination and ensure patient safety.
The recall affects 60 vials distributed nationwide in the USA and Puerto Rico. The affected batches and expiration dates are: Batch #10122105A2 (Exp 3/20/2022), #01182216A1 (Exp 5/31/2022), #02192207A1 (Exp 7/31/2022), and #03072206A1 (Exp 9/3/2022).
Healthcare providers and patients who have received this product should contact Tailor Made Compounding or the FDA for further information and guidance.
The recalled product
- Product
- GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Affected units
- 60
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 (8)
- Batch #: 10122105A2
- Exp 3/20/2022
- 01182216A1
- Exp 5/31/2022
- 02192207A1
- Exp 7/31/2022
- 03072206A1
- Exp 9/3/2022.
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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