PlainRecalls
FDA Drug Moderate Class II Terminated

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177

Reported: October 9, 2019 Initiated: September 12, 2019 #D-0042-2020

Product Description

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
6568 vials
Distribution
Nationwide
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177. Recalled by KRS Global Biotechnology, Inc. Units affected: 6568 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-0042-2020.