Plastikon Healthcare, LLC expands its voluntary nationwide recall that was initiated on June 3, 2022.
The expanded recall now includes Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This recall was initially at the retail level and has now been added to the consumer level.
This recall is initiated after third-party testing updated microorganism speciation data and includes:
- One (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension
- Lot no. 20071A expiry Jul. 2022
- NDC 0904-6846-73
- Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
- One (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension
- Lot no. 20074A expiry Jul. 2022
- NDC 0904-6840-72
- Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
- Twelve (12) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension
- Lot no. 21103A expiry Sep. 2023
- Lot no. 20046A expiry May 2022
- Lot no. 20076A expiry Jul. 2022
- Lot no. 20079A expiry Aug. 2022
- Lot no. 20080A expiry Aug. 2022
- Lot no. 20081A expiry Aug. 2022
- Lot no. 21057A expiry May 2023
- Lot no. 21059A expiry May 2023
- Lot no. 21095A expiry Sep. 2023
- Lot no. 21096A expiry Sep. 2023
- Lot no. 21099A expiry Sep. 2023
- Lot no. 21115A expiry Oct. 2022
- NDC 0904-6838-73
- Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
- Two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension
- Lot no. 20051A expiry Aug. 2022
- Lot no 20088A expiry Sep. 2022
- NDC 0904-6839-73
- Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
The consumer-level recall was initiated after it was discovered that the products contained microbial contamination.
Indications
Milk of Magnesium oral suspension is used as a laxative for temporary constipation. Magnesium Hydroxide/ Aluminum Hydroxide /Simethicone oral suspension is an anti-foaming agent, antacid, and laxative.
Risk Statement
Microbial contamination has the potential to result in infections in immune-compromised individuals. These infections could be potentially life-threatening.
To date, Plastikon Healthcare has not received any reports of adverse events related to this recall.
These products are packaged for institutional use and sold to clinics, hospitals, and pharmacies nationwide. They come in single-use cups with a foil lid. Plastikon Healthcare distributed the affected lots to Major Pharmaceuticals Distribution Center between 7/1/2020 and 10/31/2021.
The wholesaler shipped the products to nursing homes, clinics, and hospitals nationwide. These products are privately labeled for Major Pharmaceuticals.
Actions to Take
Plastikon Healthcare is notifying its consumers via a recall letter and is arranging for the return of all recalled products.
If you have an inventory of these products, please discontinue use and distribution, quarantine, and return the products to the place of purchase.
Hospitals, clinics, and healthcare providers that have distributed the affected products should inform their patients/residents of this recall.
Consumers with questions regarding this recall can contact Plastikon Healthcare at (785) 330-7109 Monday through Friday, 9:00 a.m. to 4:00 p.m. CST or by email at or by e-mail at [email protected].
Patients are advised to contact their healthcare providers if they experience any issues that may be related to the use of these products.
Adverse reactions or quality issues may be reported to the FDA’s MedWatch Adverse Event Reporting program online at https://www.fda.gov/safety/medwatch/default.htm, by completing and submitting this form or by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
