D-0891-2022 Class II Terminated
FDA drug recall D-0891-2022 was initiated by Preferred Pharmaceuticals, Inc. on May 3, 2022 and is designated Class II. Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits The recall status is terminated (terminated Sep 21, 2022). Affected quantity: 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 3, 2022
- Termination Date
- Sep 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Product Description
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 Pattern
Within the U.S in FL and CA.
Code Information
Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0891-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026