Drug Safety Alerts

Milk of Magnesia Patient-Level Recall

09/09/2019

On September 9, 2019, the United States Food and Drug Administration (FDA) issued notice regarding a patient-level recall of Milk of Magnesia 2400 mg/30 mL Oral Suspension NDC # 00904-6846-73 manufactured by Plastikon Healthcare and distributed under the Major Pharmaceuticals label.This recall was issued because the impacted lots did not meet Plastikon’s microbiological specification for Total Aerobic Microbial Count.

This recall affects lot numbers 19027D exp. 07/21 and 19027E exp. 07/21. No other lots are affected by this recall.

This product is packaged for institutional use and is sold to clinics and hospitals, and 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, 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 as indicated below. 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.

Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark^® Mail Service Pharmacies. CVS Retail indicated that they were not affected by this recall.

For more information about this recall, please contact Plastikon Healthcare at 785-330-7100, Monday through Friday, 8:00 a.m. to 5:00 p.m. (CT). 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.