Plastikon Healthcare is voluntarily recalling several lots of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension to the consumer level due to microbial contamination.
Milk of Magnesia is indicated for occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 years as recommended by a physician. Magnesium Hydroxide/Aluminum Hydroxide/Simethicone is indicated for the relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating.
The recalled lots of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension were distributed to Major Pharmaceuticals Distribution Center between July 1, 2020 and October 31, 2021 and were shipped to hospitals, nursing homes, and clinics nationwide. The following table is a list of the affected lots:
|Product Name||Strength||NDC||Lot No./Exp Date|
|Milk of Magnesia||2400mg/30mL||0904-6846-73||20071A / Jul. 2022|
|Milk of Magnesia Oral Suspension||2400mg/10mL||0904-6840-72||20074A / Jul. 2022|
|Magnesium Hydroxide/ Aluminum Hydroxide/ Simethicone Oral Suspension||1200mg/1200mg/120mg per 30mL||0904-6838-73||21103A / Sep 2023|
20046A / May 2022
20079A / Aug 2022
20080A / Aug 2022
20081A / Aug 2022
21057A / May 2023
21059A / May 2023
21095A / Sep 2023
201096A / Sep 2023
21099A / Sep 2023
21115A / Oct 2022
|Magnesium Hydroxide/Aluminum Hydroxide/ Simethicone Oral Suspension||2400mg/2400mg/240mg per 30mL||0904-6839-73||20051A / Aug. 2022|
20088A / Sep. 2022
According to the Company, patients may potentially be at an increased risk for infections requiring medical intervention if affected products are administered; those with compromised immune systems are at higher risk. To date, the Company has not received any reports of adverse events or injuries related to this recall.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Plastikon Healthcare issues voluntary nationwide recall of Milk of Magnesia oral suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone oral suspension due to microbial contamination. News release. Plastikon Healthcare, LLC. Accessed June 9, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium#recall-announcement