Recall D-0885-2022
Description: Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Recall D-0885-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0885-2022 |
Event ID | 90134 |
Distribution | Recalled product was distributed to Florida. |
Quantity | 22 bottles/90 count each |
Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
Drug Classification | Class II |
Drug Code Info | 20220601 |
Recall Initiation Date | 20220504 |
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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