Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product description
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
Lot numbers, UPCs & expiration codes
NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
Where it was sold
Nationwide distribution. No foreign or government accounts.
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-682-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 15, 2013
- FDA report date
- Jul 17, 2013
- Quantity
- 47,200 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-682-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64644
- Address
- 650 Cathill Rd
- Code information
- NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
- Postal code
- 18960-1512
- Report date
- Jul 17, 2013
- Product type
- Drugs
- Recall number
- D-682-2013
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 47,200 blister packs
- Termination date
- Apr 10, 2014
- Reason for recall
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
- Distribution pattern
- Nationwide distribution. No foreign or government accounts.
- Recall initiation date
- Mar 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 5, 2013