D-0885-2022 Class II Terminated
FDA drug recall D-0885-2022 was initiated by RemedyRepack Inc. on May 4, 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: 22 bottles/90 count each.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 4, 2022
- Termination Date
- Sep 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 bottles/90 count each
Product Description
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution Pattern
Recalled product was distributed to Florida.
Code Information
Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0885-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026