D-1004-2019 Class II Terminated
FDA drug recall D-1004-2019 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: 140,589 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
- 140,589 bottles
Product Description
Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
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 #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.