Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerc...
FDA Recall #D-0205-2018 — Class II — November 16, 2017
Product Description
Vitamin 10 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
5786 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots; 05232017@13 BUD: 11/19/2017; 05262017@2 BUD: 11/22/2017; 06022017@1 BUD: 11/29/2017; 06092017@1 BUD: 12/6/2017; 06162017@10 BUD: 12/13/2017; 08142017@10 BUD: 2/10/2018; 08252017@1 BUD: 2/21/2018; 09222017@1 BUD: 3/21/2018; 09292017@1 BUD: 3/28/2018; 10062017@1 BUD: 4/4/2018; 10132017@2 BUD: 4/11/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated