FDA: Common Stomach Medication Recalled Over Possible Contamination

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

The U.S. Food and Drug Administration (FDA) announced the recall of a common medication used to treat heartburn and stomach problems because of possible contamination.

Kansas-based Plastikon Healthcare said it voluntarily recalled three lots of Milk of Magnesia oral suspension, one lot of acetaminophen, and six lots of magnesium hydroxide “due to microbial contamination and failure to properly investigate failed microbial testing,” the FDA said in a March 24 announcement.

Contaminated products could potentially cause intestinal distress, including abdominal pain or diarrhea, although individuals with compromised immune systems have a chance of developing a widespread infection if they ingest or are exposed to the products, the FDA warned.

But so far, according to the FDA, Plastikon hasn’t received any customer complaints related to microbial concerns or reports of adverse incidents in connection to the recalled products.

“Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the FDA said.

Plastikon recommended that customers return all recalled products to the place of purchase. Patients are advised to contact their doctor or health care provider if they have any problems in connection to the contaminated products, it said.

The FDA has placed the recalled product labels and lot numbers on its website.

“The product is packaged for institutional use and is sold to clinics and hospitals nationwide in single-use cups with a foil lid,” the agency said. “The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 5/1/2020 and 6/28/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.”

According to WebMD, the medication is used for short periods to treat occasional constipation as well as “symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.”

On March 21, in a separate recall, drug giant Pfizer said it’s recalling some high blood pressure drugs due to possible cancer risk.

“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” Pfizer said in a statement. “Pfizer has notified direct consignees by letter to arrange for return of any recalled product.”

The statement indicated the recall was initiated due to nitrosamines, which can lead to increased cancer risk, and the firm believes the “benefit/risk profile of the products remains positive based on currently available data.”

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” it said.