Drug Safety Alerts

Plastikon Liquid Unit Dose Cups Consumer-Level Recall

3/24/2022

On March 24, 2022, Plastikon Healthcare, LLC issued a consumer-level recall of Milk of Magnesia USP 2400mg / 30mL Oral Suspension, Acetaminophen Oral Solution, USP 650mg / 20.3mL and Magnesium Hydroxide 1200mg / Aluminum Hydroxide 1200mg / Simethicone 120mg per 30 mL unit-dose cups distributed by and private labeled for Major Pharmaceuticals. This recall was issued due to microbial contamination and failure to properly investigate failed microbial testing.

This could be a health hazard or safety risk to patients using product(s) affected by this recall.

A list of the affected products and lot numbers is provided here.

These products 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.

These products are packaged for institutional use and sold in single use cups with a foil lid.

Plastikon has advised that anyone with an existing inventory of the lots which are being recalled should stop use and distribution, quarantine immediately, and return all quarantined product to the place of purchase. Clinics, hospitals, or healthcare providers that have dispensed product to patients are being asked by Plastikon to notify patients regarding the recall.

CVS Caremark Response:

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

For more information about this recall, please contact Plastikon by phone at 785-330-7109 or email address (sdixon@plastikon.com) Monday through Friday from 9 am to 4 pm CST. You may also contact the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.