Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commer...
FDA Recall #D-0204-2018 — Class II — November 16, 2017
Product Description
Vitamin 9 A/B Lyophilized Vial, For IM 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
3612 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 06092017@2 BUD: 12/6/2017; 07212017@16 BUD: 1/17/2018; 07312017@26 BUD: 1/27/2018; 08182017@5 BUD: 2/14/2018; 09222017@2 BUD: 3/21/2018; 09292017@2 BUD: 3/28/2018; 10062017@2 BUD: 4/4/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated