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
Reported: July 17, 2019 Initiated: June 20, 2019 #D-1460-2019
Product Description
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
Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 29106 bottles (2,619,540 tablets)
- Distribution
- Nationwide
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Macleods Pharma Usa Inc. Units affected: 29106 bottles (2,619,540 tablets).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2019. Severity: Moderate. Recall number: D-1460-2019.
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