PlainRecalls
FDA Drug Moderate Class II Terminated

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

Reported: October 9, 2019 Initiated: September 12, 2019 #D-0099-2020

Product Description

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
341 vials
Distribution
Nationwide
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588. Recalled by KRS Global Biotechnology, Inc. Units affected: 341 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-0099-2020.