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
Reported: March 27, 2019 Initiated: February 21, 2019 #D-1040-2019
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.
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 9695 bottles
- Distribution
- NJ, NY, FL
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Macleods Pharma Usa Inc. Units affected: 9695 bottles.
Why was this product recalled? ▼
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1040-2019.
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