Second Generic Zantac Recall Due to Contamination Concerns

Megan Brooks
September 27, 2019

In the wake of other recent recalls of over-the-counter generic Zantac (ranitidine), Apotex Corp has voluntarily recalled all pack sizes and formats of ranitidine tablets (75 and 150 mg) on a "precautionary basis," according to a company statement posted on the US Food and Drug Administration (FDA) website.

"To date, Apotex has not received any reports of adverse events related to use of the product," the company said.

Ranitidine is taken by millions worldwide for heartburn, gastrointestinal disorders, and discomfort.

Earlier this month, as reported by Medscape Medical News, drug regulators in the United States and Europe began investigating medicines that contain ranitidine for the presence of the likely carcinogen N-nitrosodimethylamine (NDMA), the same impurity that fueled a recall of numerous sartan blood pressure and heart failure drugs beginning last year.

Some ranitidine medicines have been found to contain low levels of NDMA.

Earlier this week, Sandoz Inc voluntarily recalled all generic Zantac products in the US due to "confirmed" contamination with NDMA in some product batches.

Last week, Sandoz's parent company Novartis halted distribution of the product in markets worldwide.

The Apotex recall is to the retail level. The recalled products were distributed nationwide to warehousing chains. The company has notified its affected direct account warehousing chains through a recall notification letter sent overnight by FedEx and is arranging for return of all recalled product.

Wholesalers, distributors, and retailers are asked to return all product to its place of purchase. "Anyone with an existing inventory of the product should quarantine the recalled lots immediately," the company noted.

Customers who bought the recalled product directly from Apotex can call Inmar Rx Solutions at 800-967-5952 (option 1) (9:00 AM to 5:00 PM EST Monday through Friday) to arrange for its return.

For more information, contact Apotex Corp at 1-800-706-5575 or by email at [email protected]

Healthcare professionals are encouraged to report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

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SOURCE: Medscape, September 27, 2019.

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