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Recall Observatory FDA recall evidence

Drug product

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

D-1003-2019

February 25, 2019

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 82196
Status
Terminated
Classification
Class II
Quantity
93227 bottles
Official record key
drug-enforcement:D-1003-2019

Official wording

Reason: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification