Drug Safety Alerts

Plastikon Expanded Liquid Unit Dose Cups Consumer-Level Recall

6/8/2022

On June 8, 2022, Plastikon Healthcare, LLC issued a consumer-level recall of 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 distributed by and privately labeled for Major Pharmaceuticals. The products are being recalled due to microbial contamination.

This may represent a potential health hazard or safety risk to plan members using product(s) affected by this recall.

A list of the affected product is provided here.

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, including but not limited to patients in hospitals and nursing homes, patients with chronic medical conditions requiring immunosuppressant or biological agents, and patients on long-term steroids, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. According to Plastikon Healthcare, as of the date of recall, it has not received any reports of adverse events or injuries related to this recall.

The products are packaged for institutional use in single use cups with a foil lid.

Plastikon recommends that consumers contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

Plastikon has advised that consumers with questions regarding this recall can contact Plastikon by phone at 785-330-7109 or by e-mail at sdixon@plastikon.com, Monday through Friday from 9 am to 4 pm CST. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.