Recalls / Class II
Class IID-1164-2022
Product
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
- Brand name
- Losartan Potassium And Hydrochlorothiazide
- Generic name
- Losartan Potassium And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Losartan Potassium
- Route
- Oral
- NDCs
- 33342-050, 33342-051, 33342-052
- FDA application
- ANDA202289
- Affected lot / code info
- Lot # BLM2114A, exp. date 07/2023
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 84/1000 count bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2022-06-10
- FDA classified
- 2022-06-27
- Posted by FDA
- 2022-07-06
- Terminated
- 2024-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1164-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.