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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

TMC Acquisition LLC dba Tailor Made Compounding: Lack of Assurance of Sterility

Agency Publication Date: July 14, 2022
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Summary

TMC Acquisition LLC dba Tailor Made Compounding is voluntarily recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable medication due to a lack of assurance of sterility. This compounded drug, sold in 30mL vials, may be contaminated with microorganisms because the manufacturing process did not meet safety standards to ensure it is sterile. Consumers who have this product should immediately stop using it and contact their healthcare provider or pharmacist, as using a non-sterile injectable drug can lead to serious infections. This recall affects four specific batches of the medication that were distributed nationwide in the USA and Puerto Rico.

Risk

The product lacks assurance of sterility, meaning it could contain bacteria or other harmful pathogens. Injecting a non-sterile medication directly into the body can cause serious or life-threatening infections, such as sepsis or localized abscesses at the injection site.

What You Should Do

  1. Check your medication vial to see if it matches the affected product: GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL in a 30mL vial labeled 'Tailor Made Compounding'.
  2. Look for the following Batch Numbers on the label: 10122110A2 (Exp 3/20/2022), 12062110A2 (Exp 4/30/2022), 02012202A2, or 02192207A1 (Exp 7/31/2022).
  3. If your product is part of this recall, stop using it immediately and do not inject the medication.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and return any unused product to the place of purchase for a refund.
  5. Contact Tailor Made Compounding directly for further instructions regarding this recall.
  6. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL (30mL-vial)
Lot Numbers:
10122110A2 (Exp 3/20/2022)
12062110A2 (Exp 4/30/2022)
02012202A2 (Exp 7/31/2022)
02192207A1 (Exp 7/31/2022)
Date Ranges: Expiration Date: 3/20/2022, Expiration Date: 4/30/2022, Expiration Date: 7/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89909
Status: Active
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Manufactured In: United States
Units Affected: 52 products (29 vials; 32 vials; 39; 657 vials; 180 vials; 39; 138 vials; 19 vials; 84 vials; 349 vials; 45; 90 vials; 60 Vials; 40 vials; 101 vials; 294 vials; 63 vials; 26 vials; 25 vials; 12 vials; 182 vials; 924 vials; 232 vials; 652 vials; 191 vials; 4 vials; 464 vials; 1,856 vials; 243 vials; 220 vials; 58 vials; 392 vials; 5,842 vials; 9,993 vials; 1,208 vials; 1,562 vials; 2,870 vials; 12 syringes; 273 vials; 4,219 vials; 41 vials; 106 vials; 58 vials; 246 vials; 176 vials; 93 vials; 414 vials; 64 vials; 75 vials; 6 vials; 15 vials; 485 Vials)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.