Sanofi, Dr. Reddy’s, Teva Recall Ranitidine Products Due to NDMA Impurity

By Emily Forster -

October 23, 2019

Several companies, Sanofi, Dr. Reddy’s Laboratories, and Teva Pharmaceutical, have initiated voluntary recalls of ranitidine products, an anti-acid, due to possible contamination with a nitrosamine impurity, N-nitrosodimethylamine (NDMA).

Sanofi says it will voluntary recall Zantac (ranitidine) over-the-counter (OTC) products in the US and Canada due to possible contamination with a NDMA, and Dr. Reddy’s Laboratories has initiated a voluntary recall of both OTC and prescription ranitidine products in the US. Teva is recalling select ranitidine products in the UK.

In September 2019, the US Food and Drug Administration and Health Canada issued public statements alerting that some ranitidine medicines, including Zantac OTC, could contain an NDMA impurity at low levels and asked manufacturers to conduct testing. The European Medicines Agency also initiated an investigation and issued guidelines for testing for nitrosamine impurities. 

Due to inconsistencies in preliminary testing results of the active ingredient used in the US and Canadian products, Sanofi said it made the decision to conduct the voluntary recall in the US and Canada as the investigation continues. Sanofi says it is working with health authorities to determine the level and extent of the recall.

Sanofi said that evaluations are ongoing for both the drug substance and finished drug product. Active ingredients used in Sanofi’s ranitidine products outside of the US and Canada are sourced from different suppliers. Sanofi says it will continue to communicate results with health authorities from the ongoing testing.

In separate news, Dr. Reddy’s Laboratories reports that it had initiated a voluntary nationwide recall in the US on October 1, 2019, (at the retail level for OTC products and at the consumer level for prescription products) of all of its ranitidine medications sold in the US due to confirmed NDMA contamination with levels above those established by the FDA. The recall includes all quantities in the US that are within expiry. To date (as of October 23, 2019), Dr. Reddy’s says it has not received any reports of adverse events related to the recall of its products.

In separate news, Teva Pharmaceutical is recalling in the UK all unexpired stock of ranitidine effervescent tablets in two dosing strengths: 150 micrograms and 300 mg. The recall is also a precautionary measure due to possible contamination with an NDMA impurity.

The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK pharmaceutical regulatory authority, reported on October 17, 2019 that an investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses. The MHRA noted that other ranitidine products have been quarantined, and the UK’s Department of Health and Social Care issued an alert on October 15, 2019 regarding shortages of the medicine and advice to healthcare professionals on alternative treatments.

Earlier this month (October 2019), GlaxoSmithKline (GSK) voluntarily recalled in the UK all unexpired stock of four Zantac prescription products: Zantac 150-mg/10-mL Syrup, Zantac 50-mg/2-mL Injection, Zantac 150-mg tablets and Zantac 300-mg tablets. GSK, Novartis’ Sandoz and Apotex had earlier announced ranitidine recalls and retailers CVS Pharmacy and Walgreens had suspended sales of ranitidine products.

Source: Sanofi, Dr. Reddy’s Laboratories, the Medicines and Healthcare Products Regulatory Agency