The parent company of Milk of Magnesia is recalling 10 lots of the product because of microbial contamination.
In a news release issued Thursday, the U.S. Food and Drug Administration said that Plastikon Healthcare LLC is voluntarily recalling the products, which were distributed at the hospital, clinic and patient level.
The recall also was deemed necessary because of a failure to properly investigate failed microbial testing, according to the release..
“This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain,” according to the release. “Individuals with a compromised immune system 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.”
The recalled items include three lots of Milk of Magnesia 2400 mg/30 mL oral suspension, one lot of acetaminophen 650mg/20.3mL, and six lots of magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone.
According to the FDA, the products are being recalled due to microbial contamination and a failure to properly investigate failed microbial testing.
The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single-use cups with a foil lid, the FDA said.
The products in question were distributed wholesale between May 1, 2021, and June 28, 2021, according to the news release.
The products are privately labeled for major pharmaceuticals.
Plastikon Healthcare advised its direct customers through a letter to return any recalled product, the company said. Clinics, hospitals, or health care providers that have dispensed products to patients have been asked to notify patients about the recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, Plastikon Healthcare said..
- Complete and submit the report online
- Regular mail or fax: Download form or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 800-332-0178.
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