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COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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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

Summary

Company Announcement Date:
April 26, 2019
FDA Publish Date:
April 29, 2019
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Recall Reason
Device & Drug Safety
Company Name:
Teva Pharmaceuticals USA, Inc
Brand Name:
Brand Name(s)
GSMS Incorporated
Product Description:
Product Description
Losartan Potassium 25 mg and 100 mg Tablets USP

Company Announcement

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

Product labels associated with the lots being recalled will be posted to the FDA website under Recalls and Alerts.


Company Contact Information

Consumers:
Teva’s Medical Information
888-838-2872
druginfo@tevapharm.com
Media:
Eric Rubin or Kelley Dougherty
973-265-3759 or 973-658-0237

Product Photos