Posted from: Wednesday, July 17, 2019 - 09:22 AM - Present

Teva Expands Recall of Losartan Potassium Tablets

June 10, 2019 – Teva Pharmaceuticals has expanded a recall of bulk losartan potassium tablets to include two additional lots of 50mg strength and four lots of 100mg strength. The active pharmaceutical ingredient (API) losartan contains a nitrosamine impurity—N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)—in excess of the U.S. FDA’s interim acceptable exposure limit of 9.82 parts per million. The API was manufactured at Hetero Labs Limited.

NMBA is a suspected human carcinogen (cancer-causing agent), and there is a potential risk that patients could develop cancer after long-term exposure to high levels of NMBA. However, because losartan potassium tablets are used to treat serious medical conditions, patients should not stop taking the recalled product before receiving a replacement product or consulting their healthcare provider about switching to an alternative. The risk of harm from stopping the medication without a replacement therapy may be greater than the risk posed by NMBA.

The recalled losartan potassium tablets were distributed through Golden State Medical Supply, Inc. Consumers who have medical-related questions or who wish to report an adverse event or quality issues related to the recalled products should contact Teva by phone at 888-838-2872 (option 3, then option 4) or email at druginfo@tevapharm.com. Adverse events can also be reported to the FDA’s MedWatch program. For returns, consumers should contact Inmar at 877-789-2065 or tevarecalls@inmar.com.

Additional details regarding the recall are available on the FDA’s website.

The recalled products were not distributed through Benecard Central Fill.

Last Updated Saturday, August 17, 2019 - 06:16 PM.