Home / Recalls / Par Pharmaceutical, Inc. / D-0120-2017

D-0120-2017 Class III

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

FDA drug recall D-0120-2017 was initiated by Par Pharmaceutical, Inc. on September 27, 2016 and is designated Class III. Reason for recall: Subpotent Drug; Ethinyl Estradiol Affected quantity: 393,981 tablets.

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
393,981 tablets

Product Description

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), 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 (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704 (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585

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-0122-2017 Class III — Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, (September 27, 2016)
  • D-0121-2017 Class III — Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 (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)

FDA data resources