Safety Report: Milk of Magnesia, Magnesium Oral Suspension products - recalled due to microbial contamination, USA

United States

Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination. To date, Plastikon Healthcare has not received any reports of adverse events or injuries related to this recall.

Risk Statement: Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product.

Product indication, lot numbers, expiration dates, and NDC information are listed in the link below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.

Plastikon Healthcare is notifying its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately. Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Consumers with questions regarding this recall can contact Plastikon Healthcare by phone at (785) 330-7109 Monday through Friday from 9 am to 4 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Company name: Plastikon Healthcare, LLC
Brand name: Plastikon Healthcare, LLC
Product recalled: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
Reason of the recall: Due to microbial contamination
FDA Recall date: June 08, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium