FDAFDA · Food and drugs·Recall number D-0119-2017
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), 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) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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