D-1040-2019 Class II Terminated
FDA drug recall D-1040-2019 was initiated by Macleods Pharma Usa Inc on February 21, 2019 and is designated Class II. Reason for recall: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. The recall status is terminated (terminated September 28, 2020). Affected quantity: 9695 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- September 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9695 bottles
Product Description
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
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Distribution Pattern
NJ, NY, FL
Code Information
Lot BLM715A, Jul-19