Class II
Terminated
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
This recall has been terminated (originally issued July 6, 2022).
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- June 10, 2022
- Posted
- July 6, 2022
- Recall Number
- D-1164-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 84/1000 count bottles
- Firm Location
- Plainsboro, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Product was distributed nationwide.
Lot / Code Info
Lot # BLM2114A, exp. date 07/2023
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