Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

FDA recall notice · announced June 1, 2022 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Notes

Distribution: Within the U.S in FL and CA.
Lot/code information: Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09.
Quantity: 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Status: Terminated
Products in this recall event:
- Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03. (D-0892-2022)
- Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09. (D-0891-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.