Why it was recalled
Failed Stability Specifications; out of specification for shear.
Product description
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Lot numbers, UPCs & expiration codes
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Where it was sold
Nationwide.
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-0724-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 223,382 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0724-2021, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 88342
- Address
- 11960 Sw 144th St
- Code information
- Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
- Postal code
- 33186-6109
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0724-2021
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 223,382 boxes
- Reason for recall
- Failed Stability Specifications; out of specification for shear.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2021