MORE GENERIC ZANTAC DRUGS RECALLED OVER POSSIBLE NDMA CONTAMINATION
Recalls of generic Zantac believed to be contaminated by a carcinogen continue to flood in. Two other firms have declared recalls of ranitidine heartburn meds in 150 mg and 300 mg doses.
The Indianapolis-based Denton Pharma, which does business as Northwind Pharmaceuticals, voluntarily recalled 10 lots of ranitidine produced by Glenmark due to unacceptable levels of the impurity N-nitrosodimethylamine (NDMA) that were found in it.
Piscataway, New Jersey-based Apco Pharma recalled eight lots that it had produced.
The news arrived even as the degree of the drug returns increased with Mylan’s impromptu recall of three lots of nizatidine capsules last week because the API in them also held dangerous levels of NDMA. It was the first time nizatidine, a drug adopted for short-term medication for duodenal ulcers, had been recognized as an NDMA-carrying culprit.
Contaminants discovered in drugs
The Nizatidine recall follows months of others along with pharmaceutical company efforts to recall the famous heartburn medicine Zantac and its generics from consumers after positive NDMA testing aroused concerns.
Last fall the FDA reported noticeable amounts of the adulterant in both branded and generic versions of the drug, initiating a set of recalls that lingered for weeks. That was all preceded by the initial spotting of NDMA and other possible carcinogens in specific "sartan"-based blood pressure meds in 2018.
It was deduced that NDMA can be developed during production and is also discovered in compounds often used in the procedure. However, a third-party lab also documented that it determined NDMA can occur during depository or haulage of drugs that originally did not test for undesirable levels.
The agency has, however, guaranteed consumers that the risk is minor, saying the levels of NDMA detected in these drugs is comparable to that often discovered in "grilled or smoked meats." The agency has also advised that it may be more dangerous for consumers to stop using these drugs than the chance of obtaining cancer from them.
Effect of recall on drug makers
While other drugmakers did not document what the cost of the recall has been, India’s Reddy’s Labs provided a decent idea of how much it had to put aside in order to cover the recall of its 33 various ranitidine stocks. It documented its North American sales in the most current quarter were below about $25 million when described in relation to the foregoing quarter. It explained much of that was to manage the recall and some was because of a supply turmoil that has since been unravelled.
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