Health Care

Here are last week’s recalls of ranitidine (Zantac) for a carcinogen’s presence

More prescription-strength ranitidine (over-the-counter brand name Zantac) has been recalled over the presence of the carcinogen NDMA.

Though some over-the-counter ranitidine, sold as store brands in addition to Zantac, tested as “reasonably safe for human ingestion” of FDA standards for NDMA content, several prescription strength versions used to treat ulcers and reflux came in with unsafe numbers.

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Monday, Golden State Medical Supply announced the recall of seven lots of 150mg ranitidine and 12 lots of 300mg ranitidine capsules made for Golden State by manufacturer Novitium Pharma. According to Golden State’s FDA-posted recall notice, these lots went mostly to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies.

Novitium recalled all lots of its Ranitidine Hydrochloride Capsules after their drug tested outside the FDA’s limits for safe consumption of NDMA. Novitium’s 300mg ranitidine tested as having 2.85 parts per million of NDMA, almost nine times the 0.32 ppm that’s the FDA’s top limit in that measurement. For the lot numbers in the Golden State Medical Supply recall, click here.

Golden State Medical Supply 150mg ranitidine made by Novitium Pharma
Golden State Medical Supply 150mg ranitidine made by Novitium Pharma FDA

Another company with ranitidine that tested with too many parts per million, Amneal Pharmaceuticals, yanked 69 lots of 150mg tablets and 22 lots of 300 mg tablets as well as three lots of 15 mg/mL syrup. For the lot numbers and expiration dates on those, click here.

Label on the 300mg Amneal Pharmaceuticals ranitidine
Label on the 300mg Amneal Pharmaceuticals ranitidine FDA

This story was originally published November 18, 2019 at 7:50 PM.

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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