FDA-Drug2013-07-17Class III
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
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
36,708 blister packs
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-684-2013Don't want to check this manually?
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