According to Teva, this recall was initiated by detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit.
Teva is voluntarily recalling 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength) to the patient level. According to Teva, this recall was initiated by detection of an impurity — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit of 9.82 ppm.
Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The recalled lots were sold exclusively to Golden State Medical Supply of Camarillo, California.
Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets. The company has been notified of Teva’s action and the tablets packaged and sold by Golden State Medical Supply is being recalled from their customers and patients.
The affected Losartan Potassium tablets being recalled are described as:
Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side.
Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.
Teva’s bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label. A complete list of newly recalled lot numbers is available on Teva’s website.
To date, Teva has not received any reports of adverse events related to the lots being recalled, the company said in a press release.
No other Losartan Potassium finished drug products from Teva in the United States have been identified as containing API above the interim specification levels set for NMBA.
Distributors and retailers that possess products being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply, according to Teva.
Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment.
Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4 or by email at firstname.lastname@example.org.
Teva's recall of 35 lots of bulk losartan potassium tablets follows multiple other recalls involving products containing valsartan, losartan and other angiotensin II receptor blockers (ARBs) that have been found to contain impurities.
Previous recalls include 10 lots of Torrent Pharmaceuticals Limited’s Losartan Potassium Tablets USP, at the consumer level, which also were manufactured by Hetero Labs Limited. Torrent's products were recalled in January due to the detection of trace amounts of N-nitrosodiethylamine (NDEA), an unexpected impurity found in an active pharmaceutical ingredient (API).
Earlier this month, the FDA issued a list of 40 ARBs that do not contain any known nitrosamine impurities.
Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply [news release]. Parsippany, NJ; April 25, 2019: Teva Pharmaceuticals. https://www.tevausa.com/news-and-media/press-releases/teva-pharmaceuticals-usa-inc.-issues-voluntary-nationwide-recall-of-losartan-potassium-25-mg-and-10/. Accessed April 26, 2019.