FDA-Drug2013-07-17Class III
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
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 distribution. No foreign or government accounts.
Affected count
47,200 blister packs
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-682-2013Don't want to check this manually?
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