Reported Nov 9, 2016 · Completed
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 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 FE 1.5/30 (norethindrone acetate1.5 mg and ethinyl estradiol tablets0.03 mgUSP and ferrous fumarate tabletsUSP 75 mg)6 blisters (28 count)NDC 0603-7608-17Rx only
- Manufactured in Canada ByPatheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
- Lot codes and dates
- Lot Numbers
4169952416995341699544185520418712741902814228446425862642586274279364427936542793664279369435931043652834365285436528643652874365288437981643798174479997450127345012744501275456336245633634563364461435946143604614361
- Lot Numbers
- Amount recalled
- 278,406 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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