Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS...
FDA Recall #D-0186-2018 — Class II — November 16, 2017
Product Description
Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion 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
963 bags
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 10112017@10 BUD: 1/9/2018; 10252017@9 BUD: 1/23/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated