According to a news report published on wtkr.com, the U.S. Food and Drug Administration, Plastikon Healthcare, LLC, is voluntarily recalling six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, one (1) lot of Acetaminophen 650mg/ 20.3mL and three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension at the patient, clinic, and hospital level. These products have been recalled due to failure to properly investigate failed microbial testing and microbial contamination.
This recalled product can potentially cause serious illnesses such as intestinal distress, abdominal pain, and diarrhea. Individuals who have a weakened immune system are more likely to develop a potentially life-threatening infection after consuming the products contaminated by micro-organisms.
As of March 24, 2022, Plastikon did not receive customer complaints connected with microbial contamination. The recalled products are packaged for institutional use and were sold to hospitals and clinics nationwide. They were packaged in single-use cups and have a foil lid.
Product lot numbers, NDC information, and expiration dates are posted in the table below. The affected products were distributed to major pharmaceuticals wholesalers between 5/1/2020 and 6/28/2021. The Major Pharmaceuticals products were shipped to nursing homes, clinics, and hospitals nationwide.
- Milk of Magnesia 2400 mg/30 mL Oral Suspension
- Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL
- Acetaminophen 650mg/ 20.3mL
Lot Numbers and Expiration Dates:
- 20024A/Mar 2022 20025A/Mar 2022 20041A/May 2022
- 20042A/May 2022 20043A/May 2022 20045A/May 2022 20046A/May 2022 20047A/May 2022 21067A/Jun 2023
- 20040A/May 2022
Consumers who have concerns or questions about the recall should contact Plastikon (plastikon.com). Patients are being urged to speak with their doctor when they experience any problems with the drug.
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