Reported Mar 20, 2019 · Terminated
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma…
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?
- Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc. Plainsboro
- NJ 08536 Manufactured byMacleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 BTN703A, BTN704A Exp Feb-19 2 BTN705A, BTN706A, Exp May-19 3 BTN707A, Exp Jun-19 4 BTN810A, Exp Jun-20 5 BTN811A, BTN812A Exp Aug-20 6 BTN813A, BTN814A, Exp Sep-20 7 BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19 8 BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20 9 BTN808A, Exp Apr-20 10 BTN809A, BTN810A, Exp Jun-20 11 BTN811A, BTN812A, Exp Aug-20 12 BTN813A, BTN814A, Exp Sep-20. - Amount recalled
- 134495 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
This product could cause temporary or reversible health problems — stop using it.
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