On June 8, 2022, Plastikon Healthcare LLC, the manufacturer of Milk of Magnesia oral suspension (2400mg/10ml) and Magnesium Hydroxide 1200mg, announced the recall of these products due to suspected microbial contamination.
The other products in the recall list include two lots of magnesium Hydroxide 2400mg/Aluminum Hydroxide and one lot of Milk of Magnesia 2400mg/30ml oral suspension.
According to FDA’s risk statement, the administration or use of any oral drug products with microbial contamination could lead to a major increase in infections requiring medical intervention.
Patients with compromised immune systems have a relatively higher probability of developing potentially life-threatening infections after using a contaminated product (s).
Even though Plastikon Healthcare LLC has not yet received any reports of adverse effects or injuries related to the recall, the company is voluntarily recalling the products as a precautionary measure.
Customers who have purchased any of the affected products have been urged to stop using them immediately and return them to their place of purchase for a full refund.
Most recalled products are packaged for institutional use and sold to hospitals, clinics, and other medical centers countrywide in single-use cups with a foil lid.
According to the recall statement, the affected lots were mostly distributed to Major Pharmaceuticals Distribution Center between July 2020 and October 2021.
The wholesalers then shipped the drugs to nursing homes, clinics, hospitals, and other medical centers nationwide. Most of the products are private labeled for leading Pharmaceuticals.
More Information on the Recall
Plastikon has already notified direct buyers to arrange for the return of the recalled products as soon as possible.
Any wholesaler with an existing inventory of any of the recalled products must stop use and distribution immediately. The company has directed that all recalled products be returned to the place of purchase.
All hospitals, clinics and nursing homes that have already prescribed the products to patients are required to notify the patients regarding the recall.
The following table (adapted from the FDA official website) shows the product indication, expiration dates, lot numbers and the NDC information for the recalled products:
| Product Name | Milk of Magnesia 2400mg/30ml oral suspension | Milk of Magnesia 2400mg/10ml oral suspension | Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg /Simethicone 120mg per 30ml oral suspension | Magnesium Hydroxide/ Aluminum Hydroxide 2400mg/ Simethicone 240mg per 30ml oral suspension |
|---|---|---|---|---|
| Indications for Use | Occasional relief of constipation in adults and kids 12 years and older | Occasional relief of constipation in adults and kids aged 12 years and older | Relief of heartburn, acid indigestion, sour stomach, stomach upset, and bloating. | Relief of sour stomach, acid indigestion, heartburn, and stomach bloating |
| Lot/Expiration Date | 20071A/July 2022 | 20074A/July 2022 | 21103A/Sep 2023 20046A/May 2022 20079A/Aug 2022 20081A/Aug 2022 21057A/May 2023 21059A/May 2023 21059A/Sep 2023 21096A/ Sep 2023 | 20051A/ Aug 2022 20088A/ Sep 2022. |
| NDC | 0904-6846-73 | 0904-6840-72 | 0904-6838-73 | 0904-6839-73 |
| Packaging | Carton containing at least 100 single-dose cups | Carton containing at least 100 single-dose cups | Carton containing at least 100 single-dose cups | Carton containing at least 100 single-dose cups |
Consumers with any queries regarding the recall are encouraged to contact Plastikon Healthcare LLC by email ([email protected]) or by phone (785) 330- 7109. The lines of communication are open from Monday to Friday between 9:00 am-4:00 pm CST.
Patients who have used the recalled products and experienced any problems that may be related to using them are highly encouraged to contact their physicians or primary healthcare providers for further assistance.
Quality problems or adverse reactions experienced as a result of using the recalled products should be reported to the FDA’s MedWatch Adverse Event Reporting program by mail, fax, or online.
You can complete and submit the report online here. Call 1-800-332-1088 to request a reporting form or download it here. Once you receive the reporting form, complete it and submit it to the FDA by fax to 1-800-FDA-0178.
