Recall D-0887-2022
Description: Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Recall D-0887-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0887-2022 |
Event ID | 90127 |
Distribution | Product was distributed to FL, SC and VA |
Quantity | 30 bottles/90 count = 2,700 tablets |
Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. |
Drug Classification | Class II |
Drug Code Info | 20220601 |
Recall Initiation Date | 20220502 |
Report Date | 20220601 |
Classification Date | 20220520 |
Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
Recalling Firm | RemedyRepack Inc. |
Initial Notification | Letter |
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