Losartan recall - Teva Pharmaceuticals/Golden State Medical Supply

On April 29th 2019, Teva Pharmaceuticals announced a recall of specific lots for Losartan 25mg tabs (6 lots) and Losartan 100mg tablets (29 lots) due to due to the detection of an unexpected impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) found in the active pharmaceutical ingredient manufactured by Hetero Labs Limited. On 6/10/19 the recall was expanded to include 2 additional lots of Losartan 50mg and 4 additional lots of Losartan 100mg. These lots were sold under the Golden State Medical Supply (GSMS) label.

What do I need to know?

• Express Scripts will mail letters to patients who have received medication impacted by the recall.
• The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
  • If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
  • If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.
• It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for these recalled products.
• To request a return kit for your recalled product, please contact Inmar (the recall coordinator for Teva/GSMS) by calling 877-789-2065 toll free between 9am to 5pm EST or email tevarecalls@inmar.com to obtain instructions and a return kit for returning the medication.
  • Explain that your pharmacy is not accepting returns of the recalled product.
  • Let the recall coordinator know that your pharmacy isn't accepting returns, and give the NDC, lot number and expiration date shown in the letter that will be mailed to you by Express Scripts. You will also need the amount you paid which is available on your summary of accounts.
  • The recall coordinator will send you a return kit with a response form you can complete and mail back. Allow at least two weeks for the return kit to arrive after requested.

Additional information is available on the FDA's website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-and-100-mg

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-expands-voluntary-nationwide-recall-losartan-potassium-50-mg-and-100-mg