The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0121-2017·Announced 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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Par Pharmaceutical, Inc. is recalling 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). The recall is due to the ethinyl estradiol component being subpotent, meaning it contains less than the labeled amount of the active ingredient.

The affected product was manufactured in Canada by Patheon, Inc., for Qualitest Pharmaceuticals, USA. A total of 822,009 tablets are involved in this recall. The product was distributed nationwide and in Puerto Rico. Specific lot numbers are listed in the recall documentation.

Consumers with this product should stop using it and contact their healthcare provider for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

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…
Manufacturer
Par Pharmaceutical, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
822,009

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: 4101072
  • 4101073
  • 4101074
  • 4149704
  • 4152054
  • 4152056
  • 4152057
  • 4159857
  • 4169950
  • 4169951
  • 4187122
  • 4187123
  • 4187124
  • 4187125
  • 4190275
  • 4190276
  • 4190278
  • 4190279
  • 4265208
  • 4265209

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Par Pharmaceutical, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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