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Recall Observatory FDA recall evidence

Drug product

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

D-682-2013

March 15, 2013

Class III

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 64644
Status
Terminated
Classification
Class III
Quantity
47,200 blister packs
Official record key
drug-enforcement:D-682-2013

Official wording

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

Code information: NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.

Distribution pattern: Nationwide distribution. No foreign or government accounts.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurity/Degradation Specification