Why it was recalled
Subpotent Drug; Ethinyl Estradiol
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0122-2017
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Sep 27, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 278,406 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0122-2017, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 75455
- Address
- 1 Ram Ridge Rd
- 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
- Postal code
- 10977-6714
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0122-2017
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical, Inc.
- Product quantity
- 278,406 tablets
- Reason for recall
- Subpotent Drug; Ethinyl Estradiol
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2016