FDA-Drug2013-07-17Class III

Camila (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 0555-0715-58

Teva Pharmaceuticals USA, Inc.
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
59,240 Cartons
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
Camila (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 0555-0715-58

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-690-2013

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