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

Agency Publication Date: July 17, 2014

Affected Products

Product: 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

Lot 3805324A Exp. 11/14

Lot Numbers:

3805324A

Product: Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

Lot 33805507A, Exp. date 11/14

Lot Numbers:

33805507A

Product: Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

Lot 33805325A, Exp.11/14

Lot Numbers:

33805325A

Product: 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

Lot 33805449A, Exp. 12/14

Lot Numbers:

33805449A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68610

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Manufactured In: United States

Units Affected: 4 products (1104 blister packs; 984 blister packs; 1125 blister packs; 5265 blister packs)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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

Lot 3805324A Exp. 11/14

Lot Numbers:

3805324A

Lot 33805507A, Exp. date 11/14

Lot Numbers:

33805507A

Lot 33805325A, Exp.11/14

Lot Numbers:

33805325A

Lot 33805449A, Exp. 12/14

Lot Numbers:

33805449A