D-1003-2019 Class II Terminated
FDA drug recall D-1003-2019 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: 93227 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
- 93227 bottles
Product Description
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
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 #: 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