Drug Recalls


On November 27, 2018 -

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.
 


For more information about this drug recall, please visit the FDA website.



On November 20, 2018 -

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength.  These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).).

For more information about this recall, please visit the FDA website.



On October 30, 2018 -

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

For more information about this recall, please visit the FDA website.



On September 6, 2018 -

Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.



On August 31, 2018 -

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

“We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald D. Ashley J.D., director of the office of compliance in the FDA’s center for drug evaluation and research. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma. It is also used to prevent bronchospasm (breathing difficulties) during exercise and to treat the symptoms of seasonal and perennial allergic rhinitis. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs) which work by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

For more information about this recall, please visit the FDA website.



UPDATED: On August 23, 2018 -

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

For more information about this recall, please visit the FDA website.



On August 8, 2018 -

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level.  This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer). 



On July 17, 2018 -

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

For more information about this recall, please visit the FDA website.



On July 13, 2018 -

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

For more information about this recall, please visit the FDA website.



On July 13, 2018 -

Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., is voluntarily recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the consumer level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), in an active pharmaceutical ingredient by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. However, at present Prinston is unaware of any evidence that NDMA has resulted in any harm to patients taking the drugs subject to this recall. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

For more information about this recall, please visit the FDA website.



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Drug Recall Process

The U.S. Food and Drug Administration (FDA) has jurisdiction over food, drugs, cosmetics, medical devices and other products and services as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In other cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. The guidelines categorize all recalls into one of the three classes according to the level of hazard involved.
  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations.

Navitus Health Solutions LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.

This plan, Navitus MedicareRx (PDP), is offered by Navitus Health Solutions and underwritten by Dean Health Insurance, Inc., A Federally-Qualified Medicare Contracting Prescription Drug Plan.