D-1164-2022 Class II Terminated
FDA drug recall D-1164-2022 was initiated by Macleods Pharma Usa Inc on June 10, 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 May 23, 2024). Affected quantity: 84/1000 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 6, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- May 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84/1000 count bottles
Product Description
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot # BLM2114A, exp. date 07/2023