Recalls / Class II
Class IID-1040-2019
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
- Affected lot / code info
- Lot BLM715A, Jul-19
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd, Bldg 200 Ste 230, Plainsboro, New Jersey 08536-3030
Distribution
- Quantity
- 9695 bottles
- Distribution pattern
- NJ, NY, FL
Timeline
- Recall initiated
- 2019-02-21
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1040-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.