Recalls / Class II
Class IID-1460-2019
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10
- 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
- BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19
Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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
- 29106 bottles (2,619,540 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-06-20
- FDA classified
- 2019-07-09
- Posted by FDA
- 2019-07-17
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1460-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.