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More prescription-strength Zantac recalled. It might have too much of a carcinogen

After a quiet December, recalls of ranitidine — brand name: Zantac — resumed Tuesday with Appco Pharma pulling all quantities and lots of 150mg and 300mg ranitidine hydrochloride capsules.

The problem, according to the company-written, FDA-posted recall notice, is NDMA-related, as has been the case with previous recalls. Recalled capsules might have more N-nitrosodimethylamine, classified as a probable human carcinogen, than FDA acceptable intake levels.

Recalled batch Nos. are 1906295UN, 1906296UN and 1906297UN for 150mg capsules in 60-count bottles with expiration date May 2021; 1905227UE and 1905228UE for 300mg capsules in 30-count bottles with expiration date April 2021; 1905225VN for 150mg capsules in 60-count bottles (expiration date April 2021); 1905226VD for 150mg capsules in 500-count bottles (expiration April 2021); and 1906298UD for 500-count bottles with expiration date May 2021.

Patients should stop taking the capsules, return them to the place of purchase if possible and discuss another form of treatment with a doctor or pharmacist.

Appco Pharma’s ranitidine was distributed by ANI Pharmaceuticals, whose logo is largest on the bottles. Anyone with questions about the recall can call Appco at 732-253-7735, Monday through Friday, 8 a.m. to 6 p.m., Eastern time; email pv@appcopharma.com; call ANI at 800-308-6755; or email PVSupport@safetycall.com.

The label from the 60-count bottles of 150mg capsules recalled
The label from the 60-count bottles of 150mg capsules recalled FDA
The label on the 300mg ranitidine recalled
The label on the 300mg ranitidine recalled FDA
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This story was originally published January 8, 2020 at 10:55 AM with the headline "More prescription-strength Zantac recalled. It might have too much of a carcinogen."

David J. Neal
Miami Herald
Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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