Why it was recalled
Subpotent Drug; Ethinyl Estradiol
Product description
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 PHARMACEUTICALS, USA, Huntsville, AL 35811
Lot numbers, UPCs & expiration codes
Lot Numbers (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
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-0119-2017
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Sep 27, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 221,017 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0119-2017, 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 (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
- Postal code
- 10977-6714
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0119-2017
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical, Inc.
- Product quantity
- 221,017 tablets
- Reason for recall
- Subpotent Drug; Ethinyl Estradiol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 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