PlainRecalls
FDA Drug Moderate Class II Terminated

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

Reported: October 9, 2019 Initiated: September 12, 2019 #D-0045-2020

Product Description

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
6447 vials
Distribution
Nationwide
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396. Recalled by KRS Global Biotechnology, Inc. Units affected: 6447 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0045-2020.