Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotec...
FDA Recall #D-0178-2018 — Class II — November 16, 2017
Product Description
Human Chorionic Gonadotropin 20,000 iu/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.
Recalling Firm
KRS Global Biotechnology, Inc — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,274 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated