PlainRecalls
FDA Drug Moderate Class II Terminated

Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reported: January 17, 2018 Initiated: November 16, 2017 #D-0174-2018

Product Description

Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Details

Units Affected
1,203 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.. Recalled by KRS Global Biotechnology, Inc. Units affected: 1,203 vials.
Why was this product recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0174-2018.