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Recall Observatory FDA recall evidence

Drug product

Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

D-0082-2019

September 20, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 81069
Status
Terminated
Classification
Class II
Quantity
1,373 60-count cartons
Official record key
drug-enforcement:D-0082-2019

Official wording

Reason: Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

Code information: Lot # 34033752A, EXP 1/2020

Distribution pattern: Product was distributed throughout the United States to various distributors who may have further distributed the product.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification