D-0895-2022 Class II Terminated
FDA drug recall D-0895-2022 was initiated by Direct Rx on May 11, 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 Dec 2, 2022). Affected quantity: 11 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 11, 2022
- Termination Date
- Dec 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 bottles
Product Description
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distribution Pattern
FL
Code Information
Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0895-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026