Reported Nov 9, 2016 · Completed
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters…
Par Pharmaceutical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Pharmaceutical, Inc. · 1 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6714
Is this the product you have?
- 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 ByPatheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
- Lot codes and dates
Lot Numbers (a) 41699494297235435929845012684614353 (b) 410106441965764228443426520642652074267685436528143652844365289450127645633544563355461435447315744731575479333247987084798709
- Amount recalled
- 221,017 tablets
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug; Ethinyl Estradiol
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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