Reported Jul 17, 2019 · Terminated
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods…
Macleods Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009
Is this the product you have?
- Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only
- Manufactured forMacleods Pharma USA inc. Plainsboro
- NJ 08536 Manufactured byMacleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10
- Lot codes and dates
BLM716AJul-19BLM717AJul-19BLM719AAug-19BLM720AAug-19BLM721ASep-19BLM722ASep-19BLM723AOct-19BLM724AOct-19BLM725AOct-19BLM726ANov-19BLM802ADec-19BLM803ADec-19BLM825ASep-21BLM826ASep-21BLM827ASep-21
- Amount recalled
- 145162 bottles (13,064,580 tablets)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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