FDAFDA · Food and drugs·Recall number D-1003-2019
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
Published March 20, 2019 · Recall initiated: February 25, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Macleods Pharma Usa Inc
- Distributor
- Nationwide within the United States
- Lot
- Lot #: BTL703A, Exp. Feb-19; BTL705A, Exp Apr-19; BTL706A, BTL707A, BTL708A, Exp May-19; BTL709A, Exp Nov-19; BTL710A, BTL711A, BTL801A, Exp. Dec-19; BTL802A, BTL803A, Exp.Feb-20; BTL804A, BTL805A, Exp. Apr-20; BTL807A, BTL807B, Exp May- 20; BTL809A, BTL810A, Exp Jul-20; BTL811A, Exp Sep-20; BTL812A, BTL813A Exp Oct-20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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