Baxter Healthcare Corporation recalls EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500;…

Recall date

August 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0050-2020

FDA classification

Class III

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide distribution - including US Nationwide distribution, and country of Canada.

Why it was recalled

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.