Reported Nov 9, 2016 · Completed
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate…
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 24 FE 1.5/30 (norethindrone acetate1 mg and ethinyl estradiol tablets0.02 mgUSP and ferrous fumarate tabletsUSP 75 mg)28 count(a) 3 blisters (NDC 0603-7610-49)and (b) 6 blisters (NDC 0603-7610-17)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) 408201840820194359320446168845012854501286 (b) 402892142586294359321446168945012874581736
- Amount recalled
- 44,127 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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