Drug recall D-0835-2022
Product
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
Lot # BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, exp. date 05/2023
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- N/A
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 15, 2022
- Terminated
- October 13, 2023
Related products
- Losartan Potassium and Hydrochlorothiazide – drug information
- NDC 33342-051 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-050 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-052 Losartan potassium and Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 · Macleods Pharmaceuticals Limited