Home / Recalls / Par Pharmaceutical, Inc. / D-0121-2017

D-0121-2017 Class III

Recalled by Par Pharmaceutical, Inc. — Chestnut Ridge, NY

Recall Details

Product Type
Drugs
Report Date
November 9, 2016
Initiation Date
September 27, 2016
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
822,009 tablets

Product Description

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

Reason for Recall

Subpotent Drug; Ethinyl Estradiol

Distribution Pattern

Nationwide and Puerto Rico

Code Information

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

Other recalls by Par Pharmaceutical, Inc.

  • D-1542-2020 Class II — BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 (August 10, 2020)
  • D-1071-2020 Class II — Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharm (March 30, 2020)
  • D-1035-2020 Class III — PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Ph (March 4, 2020)
  • D-0843-2020 Class III — Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets p (February 10, 2020)
  • D-1293-2019 Class I — Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, (April 30, 2019)
  • D-1185-2018 Class III — Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-co (September 6, 2018)
  • D-0154-2017 Class II — Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx on (October 5, 2016)
  • D-0120-2017 Class III — Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg (September 27, 2016)
  • D-0119-2017 Class III — Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.0 (September 27, 2016)
  • D-0123-2017 Class III — Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, (September 27, 2016)