FDA-Drug2014-07-23Class III

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

Teva Pharmaceuticals USA
Hazard

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Sold states
Nationwide
Affected count
5265 blister packs
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1439-2014

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