(Gray News) – The U.S. Food and Drug Administration announced two more recalls of blood pressure medication Friday because potentially carcinogenic impurities were found in them.
They were the third and fourth such recalls the agency has announced in an eight-day period.
The latest recalls are for 38 lots of Valsartan and Amlodipine and Valsartan tablets produced by AurobindoPharma USA due to “the detection of trace amounts of an unexpected impurity found in the finished drug,” and 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, from Torrent Pharmaceuticals.
The impurity in the AurobindoPharma USA products is N-nitrosodiethylamine (NDEA), which is classified as a “probable human carcinogen.” The impurity in the Torrent Pharmaceuticals products is N-Methylnitrosobutyric acid (NMBA), a “potential human carcinogen," which was found in an active pharmaceutical ingredient used in the medication.
The AurobindoPharma USA recall is an expansion of a recall initiated on Dec. 31. Here’s a list of the latest products recalled.
Here’s a list of the Torrent Pharmaceuticals products being recalled.
On Thursday, the FDA announced Camber Pharmaceuticals is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg and 100 mg because NMBA was detected in a pharmaceutical ingredient of the product.
You can find the list of lot numbers recalled by Camber Pharmaceuticals here.
Last Friday, the FDA announced Macleods Pharmaceuticals Limited recalled one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA was found in the medication.
The details on the recalled Macleods lot are:
- NDC: 33342-0052-10
- Product description: Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles
- Lot/Batch: BLM715A
- Expiration date: July 2019
Camber and Torrent said the active pharmaceutical ingredient that contained NMBA came from Hetero Labs Limited, which is based in India. Macleods said NDEA was “found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.”
None of the companies have received reports of “adverse events” related to the recalls.
All four companies recommend that patients continue taking their medication, because the harm to their health could be higher if the treatment is stopped immediately without an alternative treatment. But consult your doctor immediately.