Why it was recalled
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Product description
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
Lot numbers, UPCs & expiration codes
Lot 33805507A, Exp. date 11/14
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-1437-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 17, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 984 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1437-2014, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68610
- Address
- 1090 Horsham Rd
- Code information
- Lot 33805507A, Exp. date 11/14
- Postal code
- 19454-1505
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1437-2014
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 984 blister packs
- Termination date
- Mar 9, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification impurity test results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2014