The Department of Commerce and Consumer Affairs (DCCA) is advising all consumers not to use Ranitidine medication. (Stock photo)

The Department of Commerce and Consumer Affairs (DCCA) has advised that there has been a voluntary recall of Ranitidine medication, which has been possibly contaminated with the chemical N-nitrosodimethylamine (NDMA).

As the agency under the Ministry of Small Business, Entrepreneurship and Commerce charged with the protection of consumers, the DCCA is therefore advising all consumers not to use any of this medication.

NDMA is classified as a “probable human carcinogen”.  A carcinogen is defined as a substance capable of causing cancer in living tissue.

 The DCCA therefore supports the voluntary recalls by:

  1. GlaxoSmithKline (GSK) on its popular heartburn remedy Zantac (ranitidine) medication.  The US Food and Drug Administration (FDA) has stated that the medicine has possibly been contaminated with NDMA. They have discovered “unacceptable” levels of this carcinogen in Zantac.

Additional information on the recall may be found here.

  • Apotex Corp. of Ranitidine Tablets 75mg and 150mg (all pack sizes and Formats) to the Retail level.  Apotex has learned from the USFDA and other global regulators that some ranitidine medicines, including brand and generic formulations of ranitidine, contain a nitrosamine impurity called N-nitrosodimethylamine at low levels.

Additional information on this recall may be found by clicking here.

Sandoz Inc. of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with NDMA above levels established by the FDA.

Additional information on the recall may be found here.

The DCCA also supports Health Canada’s requests that companies stop distributing Ranitidine drugs in Canada while it assesses NDMA.  According to Health Canada, additional Ranitidine drugs are being recalled by four companies: Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC.  The lots are being recalled as they may have been manufactured using an active pharmaceutical ingredient containing an impurity, NDMA, above acceptable levels.

Additional information on this recall may be found here.

The Department of Commerce and Consumer Affairs is therefore advising all consumers in Barbados, that if they possess any of the above products, to act responsibly and immediately contact their doctor before discontinuing use, and return the product to the retail outlet from which it was purchased.

For further information, persons may contact the Department of Commerce and Consumer Affairs at 535-7000, 535-7003, 535-7005 or commerce.ca@barbados.gov.bb.

joy-ann.gill@barbados.gov.bb / DCCA

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