D-0971-2022 Class II Terminated
FDA drug recall D-0971-2022 was initiated by Direct Rx on May 5, 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 Oct 5, 2023). Affected quantity: 81 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2022
- Initiation Date
- May 5, 2022
- Termination Date
- Oct 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 bottles
Product Description
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution Pattern
AL, GA, FL, LA
Code Information
a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0971-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026