FDA Drug recall D-0123-2017
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28…
- FDA Drug
- Class III
- completed
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class III recall of Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28… by Par Pharmaceutical, citing subpotent Drug; Ethinyl Estradiol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0123-2017 |
| Classification | Class III |
| Status | completed |
| Initiated | 2016-09-27 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
Product
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Reason
Subpotent Drug; Ethinyl Estradiol
Identifiers
| code_info | Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
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FDA Drug · Class II · 2020-09-02 · Par Pharmaceutical - Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par F…
FDA Drug · Class II · 2020-04-08 · Par Pharmaceutical - PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
FDA Drug · Class III · 2020-03-25 · Par Pharmaceutical - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical - Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977…
FDA Drug · Class I · 2019-05-15 · Par Pharmaceutical
All Par Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0123-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.