Teva Pharmaceuticals USA is expanding an earlier recall of losartan potassium tablets used for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.
The product contains trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.
The expansion includes six (6) lots of bulk losartan potassium USP tablets: two lots of 50-mg strength and four lots of 100-mg strength.
- 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.
The bulk lots were sold exclusively to Golden State Medical Supply, of Camarillo, Calif, which packaged these bulk products under its own label and distributed retail bottles of 30, 90 and 1000 tablets to their customers.
The finished product lots included in this recall and listed below were sold by Teva in bulk containers.
| GSMS FG NDCs | GSMS FG NDC Description | GSMS FG Product Lots | GSMS FG Expiration Dates |
|---|---|---|---|
| 60429-317-10 | LOSARTAN POTASSIUM 50 mg TABLETS, USP 1000 tablets/bottle | GS017387 | 01/2020 |
| 60429-317-90 | LOSARTAN POTASSIUM 50 mg TABLETS 90 tablets/bottle | GS017651 | 01/2020 |
| 60429-317-30 | LOSARTAN POTASSIUM 50 mg TABLETS 30 tablets/bottle | GS017479 | 01/2020 |
| 60429-318-90 | LOSARTAN POTASSIUM 100 mg TABLETS 90 tablets/bottle | GS017042 | 01/2020 |
| 60429-318-90 | LOSARTAN POTASSIUM 100 mg TABLETS 90 tablets/bottle | GS017043 | 01/2020 |
| 60429-318-90 | LOSARTAN POTASSIUM 100 mg TABLETS, USP 90 tablets/bottle | GS017044 | 01/2020 |
| 60429-318-90 | LOSARTAN POTASSIUM 100 mg TABLETS, USP 90 tablets/bottle | GS017541 | 01/2020 |
The bulk tablet lots were repackaged into seven (7) finished product lots for further distribution by Golden State Medical Supply under its product label.
What to do
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.
Patients with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products may contact Teva Medical Information by at (888)838-2872, option 3, then, option 4, Monday-Friday, 9:00AM – 5:00PM (ET) with voicemail available 24 hours/day, 7 days/week, or by email at druginfo@tevapharm.com.
Patients wishing to return product may contact Teva’s product recall processor (Inmar) to obtain instructions and a return kit for returning their medication.
Contact Inmar at (877) 789-2065 from 9 am to 5 pm (ET) Monday – Friday) or by email Inmar at: tevarecalls@inmar.com.
Inmar will provide the materials needed to return their medication and instructions for reimbursement.
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