FDAClass IIIJuly 17, 2013

Errin (norethindrone tablets recall: Impurity Out of Spec

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA…

Why was Errin (norethindrone tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA…
Recalling firm
Teva Pharmaceuticals USA, Inc.
Quantity
154,536 cartons
Distribution
Nationwide and Puerto Rico
Recall date
July 17, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls