D-1005-2019 Class II Terminated
FDA drug recall D-1005-2019 was initiated by Macleods Pharma Usa Inc on February 25, 2019 and is designated Class II. Reason for recall: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. The recall status is terminated (terminated July 12, 2021). Affected quantity: 134495 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- February 25, 2019
- Termination Date
- July 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 134495 bottles
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Distribution Pattern
Nationwide within the United States
Code Information
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.