The Recall Desk
LowFDA (Drugs)·D-0122-2017·Announced 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.

What this means for you

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

Our severity reasoning: The agency classified this as an FDA Class III recall, 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 1.5/30 (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. The recall involves 278,406 tablets distributed nationwide and in Puerto Rico.

The recall was initiated because the product may be subpotent, specifically regarding the ethinyl estradiol component. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on appropriate action.

The recalled product

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
Manufacturer
Par Pharmaceutical, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
278,406

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: 4169952
  • 4169953
  • 4169954
  • 4185520
  • 4187127
  • 4190281
  • 4228446
  • 4258626
  • 4258627
  • 4279364
  • 4279365
  • 4279366
  • 4279369
  • 4359310
  • 4365283
  • 4365285
  • 4365286
  • 4365287
  • 4365288
  • 4379816

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 →

Related recalls

Same manufacturer · Par Pharmaceutical, Inc.

See all →

Same hazard · subpotent drug

See all →