FDAFDA · Food and drugs·Recall number D-0123-2017
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
Published November 9, 2016 · Recall initiated: September 27, 2016
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug; Ethinyl Estradiol
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Par Pharmaceutical, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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