FDA Reports Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
On June 8, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium?utm_medium=email&utm_source=govdelivery) Plastikon Healthcare's voluntarily recall of one lot of Milk of Magnesia 2,400 mg/10 ml oral suspension, one lot of Milk of Magnesia 2,400 mg/30 ml oral suspension, 11 lots of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension, and two lots of magnesium hydroxide 2,400 mg/aluminum hydroxide 2,400 mg/simethicone 240 mg per 30 ml oral suspension to the consumer level because of microbial contamination.
In the recall, Plastikon Healthcare advised that use of oral drug products with microbial contamination could result in infection, which may be life threatening for patients with compromised immune systems. To date, Plastikon Healthcare has not reported any adverse events or injuries related to the recall.
The following products are included in the recall.
|
Product Name |
Milk of Magnesia 2400 mg / 30 mL Oral Suspension |
Milk of Magnesia 2400 mg / 10 mL Oral Suspension |
Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension |
Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension |
|
Indications for Use |
Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. |
Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. |
Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas. |
Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas. |
|
Lot/Exp. |
20071A / Jul. 2022 |
20074A / Jul. 2022 |
21103A / Sep. 2023 |
20051A / Aug. 2022 |
|
NDC |
0904-6846-73 |
0904-6840-72 |
0904-6838-73 |
0904-6839-73 |
|
Packaging |
Carton containing 100 single dose cups (10 trays x 10 cups) |
Carton containing 100 single dose cups (10 trays x 10 cups) |
Carton containing 100 single dose cups (10 trays x 10 cups) |
Carton containing 100 single dose cups (10 trays x 10 cups) |
The affected lots were shipped from Major Pharmaceuticals Distribution Center from July 1, 2020–October 31, 2021, to hospitals, nursing homes, and clinics nationwide and were private labeled for Major Pharmaceuticals. The products were packaged for institutional use in single-use cups with a foil lid.
On August 4, 2022, FDA reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium?utm_medium=email&utm_source=govdelivery) that Plastikon Healthcare has expanded its recall to include lot 20076A of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension.
FDA reported that Plastikon Healthcare is notifying customers via a recall letter to arrange for return of recalled product. Anyone with an existing inventory of the recalled lots should stop use and quarantine immediately. Healthcare providers should notify patients of the recall. To date, Plastikon Healthcare has not reported any adverse events or injuries related to this recall.
Patients and consumers with questions regarding the recall can contact Plastikon Healthcare at 785-330-7109 or sdixon@plastikon.com (mailto:sdixon@plastikon.com) Monday–Friday, from 9 am–4 pm CST. Patients should contact their physician or healthcare provider if they experience any problems that may be related to taking this product.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program