PlainRecalls
FDA Drug Moderate Class II Terminated

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

Reported: October 18, 2017 Initiated: September 27, 2017 #D-0008-2018

Product Description

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

Reason for Recall

CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

Details

Recalling Firm
United Pharmacy
Units Affected
268 vials
Distribution
Nationwide.
Location
West Palm Beach, FL

Frequently Asked Questions

What product was recalled?
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417. Recalled by United Pharmacy. Units affected: 268 vials.
Why was this product recalled?
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Which agency issued this recall?
This recall was issued by the FDA Drug on October 18, 2017. Severity: Moderate. Recall number: D-0008-2018.