News from the FDA/CDC

FDA: Two repackagers issue voluntary ranitidine recall


 

The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.

Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.

“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”

The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

Find the full press release and more information on other ranitidine recalls on the FDA website.

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