Recalls expand for losartan due to impurities

Torrent Pharmaceuticals is the most recent company to update its voluntary recall of losartan potassium tablets due to trace amounts of impurities found in an active pharmaceutical ingredient. Other companies that have also recalled several lots of their products include Macleods Pharmaceuticals, Camber Pharmaceuticals, Legacy Pharmaceuticals Packaging, Teva Pharmaceuticals and Vivimed Life Sciences voluntarily recalled losartan potassium tablets because of trace amounts of impurities found in an active pharmaceutical ingredient, the FDA and the companies announced.

The recall by Camber involves a different impurity than the ones previously identified in angiotensin receptor blockers.

The initial announcement regarding the Torrent Pharmaceuticals recall in December 2018 concerned two lots, but the company expanded the recall twice in January for a total of 16 lots. The recall was expanded again in April to include 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. In September, three lots of losartan potassium tablets USP and two lots of losartan potassium/hydrochlorothiazide tablets, USP, were added to the recall.

Macleods Pharmaceuticals announced their voluntary recall of one lot on Feb. 25, 2019. The company initiated another voluntary recall on June 25, 2019 of 32 lots of losartan potassium USP tablets and losartan potassium/hydrochlorothiazide combination tablets.

On March 1, 2019, Camber Pharmaceuticals announced a recall affecting 87 lots of 25 mg, 50 mg and 100 mg losartan tablets.

On March 15, 2019, Legacy Pharmaceuticals Packaging announced a voluntary recall of three repackaged lots of 50 mg of losartan tablets. The voluntary recall was expanded to 40 additional lots of 25 mg, 50 mg and 100 mg losartan tablets on March 19, 2019 and again on April 24, 2019 to include four repackaged lots of losartan potassium tablets. This action was prompted by Camber Pharmaceuticals’ voluntary recall, according to an announcement from the company.

Teva Pharmaceuticals announced a voluntary recall on April 26, 2019 that included 35 lots of bulk losartan potassium tablets. The recall affected six lots of 25 mg strength and 29 lots of 100 mg strength, according to a press release from the company. The recall was expanded on June 11, 2019 to include six additional lots of bulk losartan potassium tablets, particularly two lots of 50 mg and four lots of 100 mg.

Losartan potassium tablets are used to treat patients with hypertension with or without left ventricular hypertrophy and those with type 2 diabetes and nephropathy.

The impurity, N-nitrosodiethylamine, was found in active pharmaceutical ingredients manufactured by Hetero Labs Limited, according to an announcement from Torrent Pharmaceuticals posted by the FDA. The impurity has been previously classified as a probable human carcinogen by the International Agency for Research on Cancer. The company is recalling lots of losartan that contain levels of nitrosodiethylamine that are higher than the acceptable intake per day, as determined by the FDA.

A different impurity — N-Nitroso-N-methyl-4-aminobutyric acid — was recently recognized through an investigation led by the FDA and resulted in the voluntary recall by Camber Pharmaceuticals, Teva Pharmaceuticals and Vivimed Life Sciences. Products affected by the Vivimed Life Sciences recall were distributed by Heritage Pharmaceuticals.

“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure,” according to a news release from the FDA. “That said, any presence of such impurities in drug products is not acceptable.”

Although Torrent Pharmaceuticals, Macleods Pharmaceuticals, Camber Pharmaceuticals, Legacy Pharmaceuticals Packaging, Teva Pharmaceuticals and Vivimed Life Sciences have not received reports of adverse events related to the impurities, patients are recommended to continue taking the medication, as the risk for harm may be worse if treatment is halted completely, according to the announcements. Patients should also contact their physician or pharmacist about an alternative treatment option or if they have experienced any adverse events.

Torrent Pharmaceuticals, Macleods Pharmaceuticals, Camber Pharmaceuticals, Legacy Pharmaceuticals Packaging, Teva Pharmaceuticals and Vivimed Life Sciences are currently notifying customers and distributors in writing and by phone, alerting them to discontinue distribution and notify their subaccounts, according to the announcement. The company is making plans for the return of all recalled products.

On Jan. 4, 2019, Torrent Pharmaceuticals announced that it is expanding the voluntary recall to 10 lots of losartan potassium tablets due to the impurity found in the active pharmaceutical ingredient produced by Hetero Labs Limited.

The recall now includes the following lots, according to an announcement from the company:

NDC 13668-115-30, 100mg, 30-count bottles, Lot BO31C016, expires on 4/2019
NDC 13668-115-90, 100mg, 90-count bottles, Lot BO31C016, expires on 4/2019
NDC 13668-115-10, 100mg, 1,000-count bottles, Lot 4DK3C005, expires on 4/2019
NDC 13668-115-10, 100mg, 1,000-count bottles, Lot 4DK3C004, expires on 4/2019
NDC 13668-115-10, 100mg, 1,000-count bottles, Lot 4DU3C040, expires on 10/2019
NDC 13668-115-10, 100mg, 1,000-count bottles, Lot 4DU3E049, expires on 5/2021
NDC 13668-115-10, 100mg, 1,000-count bottles, Lot 4DU3E050, expires on 5/2021
NDC 13668-409-30, 50mg, 30-count bottles, Lot 4L67C035, expires on 10/2019
NDC 13668-409-90, 50mg, 90-count bottles, Lot 4L67C035, expires on 10/2019
NDC 13668-409-90, 50mg, 90-count bottles, Lot 4L67C036, expires on 10/2019
NDC 13668-409-10, 50mg, 1,000-count bottles, Lot 4O50C005, expires on 11/2019
NDC 13668-113-90, 25mg, 90-count bottles, Lot 4O49C013, expires on 9/2019
NDC 13668-116-90, 50mg/12.5 mg, 90-count bottles, Lot BP02C008, expires on 3/2019
NDC 13668-116-10, 50mg/12.5 mg, 1,000-count bottles, Lot BEF7D006, expires on 3/2020
NDC 13668-117-90, 100 mg/12.5 mg, 90-count bottles, Lot BX35C020, expires on 5/2019
NDC 13668-117-90, 100 mg/12.5 mg, 90-count bottles, Lot BX35C049, expires on 8/2019
NDC 13668-117-10, 100 mg/12.5 mg, 1,000-count bottles, Lot BX35C022, expires on 05/2019
NDC 13668-117-10, 100 mg/12.5 mg, 1,000-count bottles, Lot BX35C023, expires on 05/2019

The recalled lot by Macleods Pharmaceuticals is the following:

NDC 33342-0052-10, losartan potassium/hydrochlorothiazide combination tablets 100mg/25mg, 90-count bottles, Lot BLM715A, expires on 7/2019.

The affected lots of the voluntary recall by Legacy Pharmaceutical Packaging are the following:

NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180190, expires on 10/2020
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180191, expires on 10/2020
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 181597, expires on 2/2021
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180190, expires on 10/2020
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180191, expires on 10/2020
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 181597, expires on 02/2021
NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 181598, expires on 02/2021

The expanded voluntary recall by Torrent Pharmaceuticals in September includes the following lots:

NDC 13668-409-10, losartan potassium tablets, USP 50 mg, 1,000 count, batch number 4DU2E009, expires on 12/31/2020;
NDC 13668-115-90, losartan potassium tablets, USP 100 mg, 90 count, batch number 4DU3E009, expires on 12/31/2020;
NDC 13668-115-10, losartan potassium tablets, USP 100 mg, 1,000 count, batch number 4DU3E018, expires on 2/28/2021;
NDC 13668-116-90, losartan potassium/hydrochlorothiazide tablets, USP 50 mg/12.5 mg, 90 count, batch number BEF7D051, expires on 11/30/2020; and
NDC 13668-118-90, losartan potassium/hydrochlorothiazide tablets, USP 100 mg/25 mg, 90 count, batch number 4P04D007, expires on 7/31/2020.

A list of lots affected by the voluntary recall by Camber Pharmaceuticals can be found on the FDA website.

Additional lots affected by the voluntary recall by Legacy Pharmaceutical Packaging can be found on the FDA website.

Lots affected by the expanded voluntary recall by Torrent Pharmaceuticals can also be found on the FDA website.

The list of lots affected by the voluntary recall by Teva Pharmaceuticals can be found on the FDA website. Lots affected by the expanded recall can be found on the FDA website.

A list of the 19 lots voluntarily recalled by Vivimed Life Sciences can be found on the FDA website.

Lots affected by the voluntary recall from Macleods Pharmaceuticals on June 25 can be found on the FDA website.

Editor’s Note: This article was updated on Jan. 4, 2019 and on Jan. 23, 2019 to include new information from Torrent Pharmaceuticals; on Feb. 25, 2019 to include new information from Macleods Pharmaceuticals; on March 1, 2019 to include new information from the FDA and Camber Pharmaceuticals; again on March 20, 2019 to include new information from Legacy Pharmaceutical Packaging; on April 22, 2019 to include new information from the FDA and Torrent Pharmaceuticals; on April 25, 2019 to include new information from Legacy Pharmaceutical Packaging; on April 30, 2019 to include new information from Teva Pharmaceuticals; on May 6, 2019 to include new information from the FDA and Vivimed Life Sciences; on June 12, 2019 to include new information from Teva Pharmaceuticals; on June 25, 2019 to include new information from Macleods Pharmaceuticals; and again on Sept. 23 to include new information from Torrent Pharmaceuticals.