FDA MedWatch - Milk of Magnesia Oral Suspension, Magnesium Hydroxide/Aluminum Hydroxide/Simethicone and Acetaminophen by Plastikon Healthcare: Recall

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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 and bloating commonly referred to as gas.

Acetaminophen indicated for temporarily relief of minor aches and pains due to, minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, toothache, and temporarily reduction of fever.

RECOMMENDATIONS:

• Patients are advised to contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 
• Patients with questions regarding this recall can contact the company.
• Clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.