Medications & Supplements/Prescription Drugs

United Pharmacy: Glutamine, Arginine and Carnitine Injection Recalled for Impurities

Agency Publication Date: October 10, 2017

Summary

United Pharmacy is recalling 268 vials of its Glutamine, Arginine and Carnitine (10/100/200mg/mL) compounded injection. Testing by the FDA revealed that the product does not contain any of the listed glutamine and contains two unknown impurities. These deviations from manufacturing standards mean the medication is not as described on the label and may contain unintended substances.

Risk

The product lacks a primary active ingredient (glutamine) and contains two unknown impurities, which could result in patients not receiving their intended treatment or experiencing adverse reactions from the unidentified contaminants.

What You Should Do

Identify your product by checking the label for 'Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial)' with United Pharmacy Compounded labeling.
Check the vial for Lot: GAC-12 with a 'Beyond Use Date' (BUD) of 11/10/17 or Lot: GAC-13 with a BUD of 01/14/18.
Contact your healthcare provider or pharmacist immediately for guidance if you have been using these specific lots.
Return any unused vials to the pharmacy where you purchased them for a refund.
Contact United Pharmacy at their West Palm Beach location for further instructions regarding this recall.
For additional questions or to report side effects, call 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

Drug recall guidance for compounded injections

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

Affected Products

Product: Glutamine, Arginine and Carnitine Injection (30 mL)

Model:

D-0008-2018

Lot Numbers:

GAC-12 (BUD 11/10/17)

GAC-13 (BUD 01/14/18)

Date Ranges: BUD 11/10/17, BUD 01/14/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78183

Status: Resolved

Manufacturer: United Pharmacy

Sold By: United Pharmacy

Manufactured In: United States

Units Affected: 268 vials

Distributed To: Nationwide

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.

Summary

What You Should Do

Identify your product by checking the label for 'Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial)' with United Pharmacy Compounded labeling.

Check the vial for Lot: GAC-12 with a 'Beyond Use Date' (BUD) of 11/10/17 or Lot: GAC-13 with a BUD of 01/14/18.

Contact your healthcare provider or pharmacist immediately for guidance if you have been using these specific lots.

Return any unused vials to the pharmacy where you purchased them for a refund.

Contact United Pharmacy at their West Palm Beach location for further instructions regarding this recall.

For additional questions or to report side effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.