Par announced a voluntary recall of certain lots of Gildess, Gildess FE, and Gildess 24 FE products due to a decreased level of ethinyl estradiol.
The affected products are as follows:
- Gildess 1.5/30, NDC 0603-7606-48, 3×21 tablets
- Gildess 1.5/30, NDC 0603-7606-15, 6×21 tablets
- Gildess 1/20, NDC 0603-7607-48, 3×21 tablets
- Gildess 1/20, nDC 0603-7607-15, 6×21 tablets
- Gildess Fe 1/20, NDC 0603-7609-17, 6×28 tablets
- Gildess Fe 1.5/30, NDC 0603-7608-17, 6×28 tablets
- Gildess 24 Fe, NDC 0603-7610-49, 3×28 tablets
- Gildess 24 Fe, NDC 0603-7610-17, 6×28 tablets
Gildess (norethindrone acetate and ethinyl estradiol) is indicated to prevent pregnancy in women who elect to use oral contraceptives as a method of contraception. Gildess FE contains an additional ferrous fumarate component to facilitate ease of drug administration via a 28-day regimen. It is non-hormonal and does not serve any therapeutic purpose.
Par has notified all locations which have received direct shipment of these lots. Any further distribution of these lots should be discontinued and any remaining quantity should be quarantined.
For more information call (800) 967-5952 or visit ParPharm.com.