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Recall Observatory FDA recall evidence

Drug product

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

D-689-2013

March 15, 2013

Class III

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 64643
Status
Terminated
Classification
Class III
Quantity
154,536 cartons
Official record key
drug-enforcement:D-689-2013

Official wording

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information: Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurity/Degradation Specification