Reported Nov 9, 2016 · Completed
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets,…
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 FE 1/20 (norethindrone acetate1 mg and ethinyl estradiol tablets0.02 mgUSP and ferrous fumarate tabletsUSP 75 mg)28 count6 blisters (NDC 0603-7609-17)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
95 of 95 codes
410107241010734101074414970441520544152056415205741598574169950416995141871224187123418712441871254190275419027641902784190279426520842652094265210426521142652124265213426521442652154265216426653542665364266537426653842665394267686426768742676884267689432988843349974334998433499943593034359304435930543593064359307435930843621414362142436214343621444362145436528243679234367924436792543679264367927436792843679294467392
- Lot Numbers
- Amount recalled
- 822,009 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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