FDAFDA · Food and drugs·Recall number D-1005-2019
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
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 #: BTN703A, BTN704A Exp Feb-19; BTN705A, BTN706A, Exp May-19; BTN707A, Exp Jun-19; BTN810A, Exp Jun-20; BTN811A, BTN812A Exp Aug-20; BTN813A, BTN814A, Exp Sep-20; BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19; BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A, BTN810A, Exp Jun-20; BTN811A, BTN812A, Exp Aug-20; BTN813A, BTN814A, Exp Sep-20.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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