Trace Amounts of N-Nitrosodiethylamine (NDEA) Prompt Recall of Valsartan Drugs, Other Products

April 25, 2019

Legacy Pharma Expands NMBA Recall Notice

Note: This article was updated on 04.25.19 

Mylan Pharmaceutical’s voluntary recall of its valsartan -containing blood pressure medications triggered an avalanche of recalls from other companies who produce valsartan drugs. 

According to the reports listed by the FDA, the recalls have been announced after traces of API impurities N-Nitrosodiethylamine (NDEA), a ‘probable’ human carcinogen, and N-Nitroso N-Methyl-4-amino butyric acid (NMBA), a ‘potential’ human carcinogen. 

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The EPA regards “probable human carcinogens” as agents with sufficient evidence from animal studies, but limited or nonexclusive human evidence, to be regarded as carcinogenic. ‘Potential’ or ‘possible human carcinogens’ are agents with limited animal evidence and little or no human data to support carcinogenic effects. 

Losartan and Valsartan recalls began in 2018 and have continued throughout the first part of 2019. Patients who are on Losartan should continue taking their medications despite the recall notices, as immediate cessation without a readily available alternative is a reportedly greater health risk than consuming either probable or possible carcinogen.

The following lists are compilations of recalls starting in December 2018. Hyperlinks provide comprehensive, specific lot recall information.

 

Complete, Updated List of Valsartan Products Under Recall

 

Continue to page 2 for a list of NDEA recalls

Click Here for NMBA recalls

Recalls Due to Traces of NDEA

 

Torrent Pharmaceuticals Limited

Torrent’s Losartan potassium and potassium/hydrochlorothiazide combination tablet recalls began in early 2019. 

As of April 18th, the company has recalled…

  • 6 lots of Potassium/Hydrochlorothiazide combination tablets containing NDEA

  • 10 lots of Potassium tablets containing NDEA

Prinsoton Pharmaceutical Inc. dba Solco Helathcare LLC

As of January 18th, Prinston has recalled one lot of Irbesartan and 7 Lots of Irbesarten HCTZ tablets indicated for hypertension control and the treatment of heart failure, due to trace amounts of NDEA. 

 

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Macleods Pharmaceuticals Limited

On February 22nd, Macleods recalled one lot of Losartan Potassium/Hydrochlorothiazise combination tablets (100 mg / 25 mg) due to NDEA impurities found in products manufactured by Hetero Labs Limited. 

No adverse events were reported the time of the recall notice. 

AurobindoPharma USA, Inc.

On March 1st, AurbindoPharma expanded its Valsartan tablets and Valsartan/Amlodipine combination tablets to 39 lots. 

 

Continue to page 3 for NMBA recalls

Recalls Due to Traces of NMBA

Chamber Pharmaceuticals Inc. 

On February 28th, Chamber recalled 87 lots of 25 mg, 50 mg, and 100 mg Losartan Tablets.

Torrent Pharmaceuticals Limited

Included in the April 18th recall notice were 96 lots of Losartan Potassium tablets and Losartan Potassium/Hydrochlorothiazide tablets that potentially contained NMBA. 

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Legacy Pharmaceutical Packaging LLC

As of April 24th, 2019, Legacy has recalled 36 lots of 25 mg, 50 mg, and 100 mg Losartan tablets in response to Torrent Pharmaceutical’s recall notice. 

The company’s March 25threcalls, which saw the greatest expansion - 30 repackaged lots of Losartan - was issued in response to Chamber Pharmaceutical’s recall notice. On April 29th, the company increased their expansion by one aditional lot of losaratn tablets made with API manufactured by Hetero Labs.

 

 

Golden State Medical Supply

44 lots of losartan potassium tablets were recalled on April 29th. Recalled products were manufactured by Hetero Labs

Click here for NDEA recalls