Recalls / Class III
Class IIID-0121-2017
Product
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
- Affected lot / code info
- Lot Numbers: 4101072, 4101073, 4101074, 4149704, 4152054, 4152056, 4152057, 4159857, 4169950, 4169951, 4187122, 4187123, 4187124, 4187125, 4190275, 4190276, 4190278, 4190279, 4265208, 4265209, 4265210, 4265211, 4265212, 4265213, 4265214, 4265215, 4265216, 4266535, 4266536, 4266537, 4266538, 4266539, 4267686, 4267687, 4267688, 4267689, 4329888, 4334997, 4334998, 4334999, 4359303, 4359304, 4359305, 4359306, 4359307, 4359308, 4362141, 4362142, 4362143, 4362144, 4362145, 4365282, 4367923, 4367924, 4367925, 4367926, 4367927, 4367928, 4367929, 4467392, 4467393, 4467394, 4467395, 4482870, 4487638, 4501269, 4501270, 4506358, 4563356, 4563357, 4563358, 4563359, 4563360, 4563361, 4572329, 4572331, 4572332, 4572333, 4583326, 4614355, 4614356, 4614357, 4615487, 4696445, 4696446, 4698118, 4731576, 4731577, 4731578, 4731579, 4731580, 4798710, 4798711, 4798712, 4798713
Why it was recalled
Subpotent Drug; Ethinyl Estradiol
Recalling firm
- Firm
- Par Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 822,009 tablets
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-09-27
- FDA classified
- 2016-11-01
- Posted by FDA
- 2016-11-09
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0121-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.