FDAClass IIINovember 9, 2016

Gildess FE 1/20 recall: Subpotent

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…

Why was Gildess FE 1/20 recalled?

Subpotent Drug; Ethinyl Estradiol

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Par Pharmaceutical, Inc.
Quantity
822,009 tablets
Distribution
Nationwide and Puerto Rico
Recall date
November 9, 2016
Classification
Class III
Status
Completed
Agency
FDA (drug)
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