Class II
Terminated
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
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- February 25, 2019
- Posted
- March 20, 2019
- Recall Number
- D-1003-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 93227 bottles
- Firm Location
- Plainsboro, NJ, United States
Reason for Recall
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Distribution
Nationwide within the United States
Lot / Code Info
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
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