Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biot...
FDA Recall #D-0173-2018 — Class II — November 16, 2017
Product Description
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), 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
2,239 tablets
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lot: 06132017@22 BUD: 12/10/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated