Class II
Terminated
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
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- February 21, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1040-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9695 bottles
- Firm Location
- Plainsboro, NJ, United States
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Distribution
NJ, NY, FL
Lot / Code Info
Lot BLM715A, Jul-19
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