Recall report: Children's auto-immune disease drug contaminated with mold and yeast
A drug used to treat an auto-immune disease in children has been voluntarily recalled by drugmaker Jacobus Pharmaceutical after reports of the tablets being contaminated with yeast, mold and aerobic bacteria.
Three lots of Ruzurgi 10 mg tablets, used to treat Lambert-Eaton myasthenic syndrome, have been recalled. The use of the drug increases the risk of serious infection, the FDA said.
Two of the three lots of expiration dates of March 2023, while a third has an expiration date of May 2023. The lots have control numbers 18038, 18039 and 18079.
A Canadian partner company performing testing on the drug informed Jacobus of the problem in one lot, which led to an expanded investigation that identified the other two.
Anyone who believes they might have side effects from the product’s use should call the FDA, or complete an online report.
Patients with Lambert-Eaton myasthenic syndrome suffer from their own immune system attacking their tissues, at the connections between nerve and muscles, which interferes with the ability to send signals to muscle cells. The disease can cause weakness, and difficulty walking or taking care of oneself, in addition to difficulty in talking, swallowing or chewing.
One lot of Azurity’s drug for Clostridium difficile-associated diarrhea, and enterocolitis has also been recalled, the company announced last week, for a mix up of the diluent included in the kit.
Firvanq, Vancomycin 50 mg/mL has been recalled because the kit contains a First Omeprazole (FIRST-PPI) diluent instead of a Firvanq diluent bottle, the FDA said. The mixup could be especially vulnerable to elderly and immunocompromised patients.
“There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death,” the warning said.