Parsippany-based Teva Pharmaceuticals USA Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets.
In a press release, the company said that the expanded recall includes six lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the U.S. Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Ltd., which was used in the manufacturing of the six bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.
For more information on the previous recall initiated on April 25, 2019, click here.
Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The bulk lots were sold exclusively to Golden State Medical Supply Inc. of Camarillo, Calif.
Golden State Medical Supply Inc. packaged these bulk products under its own label and distributed retail bottles of 30, 90 and 1000 tablets to their customers.
The affected losartan potassium tablets being recalled are described as:
- Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK|50” 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 promptly notified Golden State Medical Supply Inc. of the presence of the impurity in Hetero’s API and Teva will recall six lots of bulk losartan potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply Inc., will be sub-recalled from their customers and patients. Distributors and retailers that have product 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 Inc.
Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding 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. For full drug product information, please refer to the full prescribing information for losartan potassium tablets USP.
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. Live calls are received Monday-Friday, 9:00 a.m. 5:00 p.m. Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at firstname.lastname@example.org.
Adverse reactions or other problems experienced with the use of these products should also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm.
- Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Patient safety and product quality are critical to Teva. As always, Teva and Golden State Medical Supply will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.