FDA recall D-0891-2022
Preferred Pharmaceuticals, Inc. · Class II · drug
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
Distribution
Within the U.S in FL and CA.
Key facts
- Status
- Terminated
- Initiation date
- 2022-05-03
- Report date
- 2022-06-01
- Termination date
- 2022-09-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Anaheim, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2022