Par Pharmaceutical, Inc. recalls Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets,…
- Recall date
- September 27, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0121-2017
- FDA classification
- Class III
- Brand / firm
- Par Pharmaceutical, Inc.
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Subpotent Drug; Ethinyl Estradiol
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
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