Recall – Milk of Magnesia

March 30, 2022
TOPIC: Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL, and Acetaminophen 650 mg/ 20.3 mL, Unit Dose Cups by Plastikon Healthcare: Recall – Due to Microbial Contamination

AUDIENCE: Patient, Health Professional

ISSUE: Plastikon Healthcare is recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650 mg/ 20.3 mL, and six (6) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL due to microbial contamination and failure to properly investigate failed microbial testing.

This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain. Individuals with a compromised immune system have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.

To date, Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall. For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND:

Milk of Magnesia is indicated for the occasional relief of constipation
(irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.

Magnesium Hydroxide/Aluminum Hydroxide/Simethicone is indicated for relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure