Recalls / Class III

Class IIID-0123-2017

Product

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Affected lot / code info

Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736

Why it was recalled

Subpotent Drug; Ethinyl Estradiol

Recalling firm

Firm

Par Pharmaceutical, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714

Distribution

Quantity

44,127 tablets

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2016-09-27

FDA classified

2016-11-01

Posted by FDA

2016-11-09

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0123-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.