The Food and Drug Administration has announced the voluntary recall of Lawrence, KS, Plastikon Healthcare, LLC Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count.
This product is packaged for institutional use and is sold to clinics and hospitals, the patient population most likely to use the product are likely immunocompromised. 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.
To date, FDA says Plastikon has not received any customer complaints or reports of adverse events related to this issue. Milk of Magnesia 2400 mg/ 30 mL 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.
Milk of Magnesia 2400 mg/ 30 mL Oral Suspension is privately labeled by Major Pharmaceuticals and packaged in cartons. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler), who may have shipped to clinics, hospitals and healthcare providers, in the United States, in August 2019.
Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product.
For more information and lot numbers visit FDA.
