Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Mislabeling
Reason Mislabeling
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