The Recall Desk
ModerateFDA (Drugs)·D-0120-2017·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2 because it is unlikely to cause adverse health consequences. A score of 2 is assigned due to the potential for reduced contraceptive efficacy.

Plain-English summary

Par Pharmaceutical, Inc. is recalling Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP), 21 count, because the product contains subpotent levels of ethinyl estradiol. The affected product is a prescription-only oral contraceptive manufactured in Canada by Patheon, Inc. for Qualitest Pharmaceuticals, USA.

The recall involves 393,981 tablets in two package configurations: 3 blisters (NDC 0603-7607-48) and 6 blisters (NDC 0603-7607-15). The affected lots were distributed nationwide and in Puerto Rico. Specific lot numbers for the 3-blisters include 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, and 4798704. Specific lot numbers for the 6-blisters include 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, and 4936585.

Consumers should check their medication for these specific NDCs and lot numbers. If the product matches the recalled items, they should contact their healthcare provider or pharmacist for guidance on alternative contraception and proper disposal of the recalled medication.

The recalled product

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 PHARM
Manufacturer
Par Pharmaceutical, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
393,981

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 (a) 4101059
  • 4101062
  • 4190536
  • 4265205
  • 4359294
  • 4501265
  • 4572326
  • 4651818
  • 4731571
  • 4798704 (b) 4187113
  • 4187114
  • 4187115
  • 4190273
  • 4190274
  • 4190280
  • 4265203
  • 4265204
  • 4359296
  • 4367922
  • 4379814

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.

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Same hazard · subpotent drug

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