Key Takeaway

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Cana by Par Pharmaceutical Inc. was recalled on September 27, 2016. The hazard: Subpotent Drug; Ethinyl Estradiol

FDA Drug Class III Completed

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Cana

Recalled: September 27, 2016 ~393,981 tablets units affected D-0120-2017

Description

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Hazard / Reason

Subpotent Drug; Ethinyl Estradiol

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Cana

Drugs

Company Information

Par Pharmaceutical Inc.

Spring Valley, NY, United States

View all 16 recalls by Par Pharmaceutical Inc. →

Distribution

Nationwide and Puerto Rico

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Frequently Asked Questions

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What remedy is available for this recall?

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