Home / Recalls / Par Pharmaceutical, Inc. / D-0122-2017

D-0122-2017 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
278,406 tablets

Product Description

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, 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: 4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626, 4258627, 4279364, 4279365, 4279366, 4279369, 4359310, 4365283, 4365285, 4365286, 4365287, 4365288, 4379816, 4379817, 4479997, 4501273, 4501274, 4501275, 4563362, 4563363, 4563364, 4614359, 4614360, 4614361

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)