USA

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

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The 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.

To date, Teva has not received any reports of adverse events related to the lots being recalled.

No other Teva Losartan Potassium finished drug products have been identified, in the United States, containing API above the interim specification levels set for NMBA.

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 promptly notified Golden State Medical Supply of the presence of the impurity in Hetero’s API and Teva will recall thirty-five (35) lots of bulk Losartan Potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply, will be 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.

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. 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, 9:00AM-5:00PM Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.

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.

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.

Lots Under Voluntary Recall

The finished product lots that are included in this voluntary recall and listed below were sold by Teva in bulk containers. The tablets were repackaged for further distribution by Golden State Medical Supply under its product label. The bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label.

                         
GSMS FG NDCs      

GSMS FG
NDC Description

     

GSMS FG
Product Lots

     

GSMS FG
Expiration
Dates

60429-318-90      

Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle

      GS014045       06/2019
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS014305       06/2019
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS014054       06/2019
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS014044       06/2019
60429-316-10       Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count Bottle       GS014817       06/2019
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS015172       06/2019
60429-316-10       Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count Bottle       GS015204       06/2019
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016338       12/2019
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016341       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016342       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016343       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016344       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016345       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS016535       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS016524       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016539       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016969       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS016973       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS017337       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017384       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017385       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017539       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017540       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017543       01/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017542       01/2020
60429-318-10       Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count Bottle       GS018524       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017984       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017985       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS017986       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS018263       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS018264       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS017634       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS017653       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS017980       02/2020
60429-316-30       Losartan Potassium, Tablets, USP, 25 mg, 30 Count Bottle       GS017981       02/2020
60429-318-90       Losartan Potassium, Tablets, USP, 100 mg, 90 Count Bottle       GS018265       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS016726       02/2020
60429-316-30       Losartan Potassium, Tablets, USP, 25 mg, 30 Count Bottle       GS016958       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS017045       02/2020
60429-316-90       Losartan Potassium, Tablets, USP, 25 mg, 90 Count Bottle       GS017276       02/2020
60429-316-30       Losartan Potassium, Tablets, USP, 25 mg, 30 Count Bottle       GS017341       02/2020
60429-316-10       Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count Bottle       GS018318       02/2020
60429-316-10       Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count Bottle       GS017342       02/2020
60429-316-10       Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count Bottle       GS017808       02/2020
                         

Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods.

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

  • Contact Inmar at 877-789-2065 (Hours of operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: tevarecalls@inmar.com.
  • Inmar will provide the materials needed to return their medication and instructions for reimbursement.
  • Customers of Golden State Medical Supply may:
    • Call: (800) 284-8633, ext. 215
    • Fax: (805) 437-7582
    • Email: recalls@gsms.us

 

Golden State Medical Supply Product Labels

Golden State Medical Supply Product Labels

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