The product contains trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.
Legacy has not received any reports of adverse events to date.
The following four repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) , are being recalled:
| LEGACY NDC# | Name and Strength | Count | Legacy Lot # | Expiry |
|---|---|---|---|---|
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180190 | 10/2020 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180191 | 10/2020 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181597 | 02/2021 |
| 68645-494-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181598 | 02/2021 |
The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.
The recalled product was distributed by pharmacies nationwide.
What to do
Legacy is notifying its customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services.
Instructions for returning recalled products are provided in the recall letter.
Consumers with questions may contact Inmar at (877) 538-8443, Monday – Friday, 9am – 5pm EST.