Reported Mar 20, 2019 · Terminated
Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, 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?
- Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc. Plainsboro
- NJ 08536 Manufactured byMacleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19 2 TM708A,BTM709A, Exp Apr-19 3 BTM710A, Exp Jun-19 4 BTM711A, BTM712A, Exp Oct-19 5 BTM713A,BTM714A, BTM715A, Exp Nov-19 6 BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19 7 BTM806A,BTM807A, Exp Mar-20 8 BTM809A Exp Apr-20 9 BTM810A, BTM811A, BTM812A, Exp. Jul-20 10 BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20 11 BTM818A, BTM819A Exp Nov-20. - Amount recalled
- 140,589 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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