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Recall Observatory FDA recall evidence

Drug product

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

D-0307-2019

November 27, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 81646
Status
Ongoing
Classification
Class II
Quantity
41,572 bottles
Official record key
drug-enforcement:D-0307-2019

Official wording

Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Code information: NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011

Distribution pattern: USA Nationwide including Puerto Rico.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity, N-nitrosodimethylamine (NDEA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations