D-0887-2022 Class II Terminated
FDA drug recall D-0887-2022 was initiated by RemedyRepack Inc. on May 2, 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 2, 2022). Affected quantity: 30 bottles/90 count = 2,700 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- Sep 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 bottles/90 count = 2,700 tablets
Product Description
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution Pattern
Product was distributed to FL, SC and VA
Code Information
Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0887-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026