Drug product

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

D-0891-2022

May 03, 2022

Class II

Product summary

Firm: Preferred Pharmaceuticals, Inc.
Event: Event 90148
Status: Terminated
Classification: Class II
Quantity: 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Official record key: drug-enforcement:D-0891-2022

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

Code information: Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09.

Distribution pattern: Within the U.S in FL and CA.

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

AZIDO Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations