Ailments such as heartburn, indigestion, and general aches and pains are experienced by millions of people on a daily basis. That’s why medications used to treat these pesky issues are relied on as tried and true methods to knock out a headache or calm an upset stomach. However, sometimes otherwise reliable treatment approaches can do more harm than good. Read on to learn more about the U.S. Food & Drug Administration’s (FDA) recent recall warning for three common medications.
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Due to microbial contamination, as well as “failure to properly investigate failed microbial testing,” the pharmaceutical company Plastikon Healthcare is recalling three lots of Milk of Magnesia oral suspension, one lot of Acetaminophen, and six lots of Magnesium Hydroxide/Aluminum Hydroxide/Simethicone. These medications are solely for institutional use, meaning they are sold to hospitals and clinics across the U.S., but cannot be bought directly by consumers.
The FDA announced the voluntary recall on March 24, warning consumers that the use of the products could cause illness “due to intestinal distress” in the form of diarrhea or abdominal pain. On a more serious note, those with compromised immune systems are at greater risk if given these medications, the agency warned. According to the statement announcing the recall, these individuals “have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.”
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These medications are used to treat common conditions, ranging from indigestion to aches and pains. Milk of Magnesia, for example, is used for the occasional relief of constipation in adults and children 12 years and older. Acetaminophen, which is also known by one of its common brand names, Tylenol, is used for pain relief. The liquid form that has been recalled is used to treat pain from arthritis, muscular aches, backache, the common cold, temporary reduction of fever, among other issues, per the FDA release. Finally, the recalled combination of Magnesium Hydroxide/Aluminum Hydroxide/Simethicone is administered for heartburn relief, an upset stomach, or uncomfortable pressure and bloating.
While these medications are not for direct sale to consumers, the affected lots were shipped to hospitals, nursing homes, and clinics across the country, potentially putting already compromised patients at risk. Affected lots were distributed between May 1, 2020 and June 28, 2021, and were private labeled for the wholesaler, Major Pharmaceuticals, according to the FDA release. Plastikon Healthcare also issued a recall letter to its direct customers, alerting them about the recall.
All medications came in single-use cups with a foil lid, and each product has a National Drug Code, or NDC, from the FDA, which can help identify recalled products. Milk of Magnesia (NDC: 0904-6846-73) was packaged in a carton with 100 single dose cups, with 10 trays of 10 cups. The products in question had expiration dates of March 2022 (lot numbers: 20024A and 20025A) and May 2022 (lot number: 20041A).
The recalled Acetaminophen also came in a carton with 100 single doses (NDC: 0904-6820-76), and the affected lot number was 20040A, which had an expiration date of May 2022. Four of the affected lots of the Magnesium Hydroxide formulation were set to expire in May 2022 (lot numbers: 20042A, 20043A, 20045A, 20046A, and 20047A), as well as one that was set to expire in June 2024 (lot number: 21067A).
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Patients can find some solace in the fact that the FDA has not received any reports of adverse events or microbial concerns from consumers in relation to the recall. Any patients who fear they may have experienced issues related to use of these medications are asked to contact their doctor or healthcare provider.
In the event of an adverse reaction or quality problems, the FDA has options to report online, or to download a form and submit through regular mail or via fax. For questions about the recall specifically, consumers can direct questions to Plastikon via phone at 785-330-7109 or email at [email protected], Monday through Friday, 9 a.m. to 4 p.m. Central Standard Time.
Hospitals or healthcare clinics with these products in their inventory were advised to quarantine products and stop distribution and administration immediately, the FDA release explains. Recalled products are to be returned to the place of purchase, and any healthcare providers that have dispensed affected products are asked to notify their patients about the recall.
“Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the FDA statement reads. “Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product.”
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