Reported Mar 20, 2019 · Terminated
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 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 40mg/12.5 mg, 30-count bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc. Plainsboro, NJ 08536
- Manufactured forMacleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 BTL703A, Exp. Feb-19 2 BTL705A, Exp Apr-19 3 BTL706A, BTL707A, BTL708A, Exp May-19 4 BTL709A, Exp Nov-19 5 BTL710A, BTL711A, BTL801A, Exp. Dec-19 6 BTL802A, BTL803A, Exp.Feb-20 7 BTL804A, BTL805A, Exp. Apr-20 8 BTL807A, BTL807B, Exp May- 20 9 BTL809A, BTL810A, Exp Jul-20 10 BTL811A, Exp Sep-20 11 BTL812A, BTL813A Exp Oct-20 - Amount recalled
- 93227 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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