The Recall Desk

FDA (Drugs) recall action 75455

Par Pharmaceutical, Inc. recalled 5 products on 2016-11-09

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2016-11-09
Critical
0
Units
1,759,540

Why these products were recalled

Subpotent Drug; Ethinyl Estradiol

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Drugs)··2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

    Product
    Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1/20 tablets because the ethinyl estradiol component is subpotent. The recall covers 822,009 tablets distributed nationwide and in Puerto Rico.

    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1/20 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers 393,981 tablets distributed nationwide and in Puerto Rico.

    Product
    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

    Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc.…
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1.5/30 tablets because they may contain subpotent levels of ethinyl estradiol.

    Product
    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…
    Category
    Distribution
    1 state