FDA-Drug2014-07-23Class III

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide
Affected count
1104 blister packs
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1436-2014

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