Why it was recalled
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Product description
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
Lot numbers, UPCs & expiration codes
Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
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-1397-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2012
- FDA report date
- Jul 4, 2012
- Quantity
- 100,761 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1397-2012, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61776
- Address
- 650 Cathill Rd
- Code information
- Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
- Postal code
- 18960-1512
- Report date
- Jul 4, 2012
- Product type
- Drugs
- Recall number
- D-1397-2012
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 100,761 cartons
- Termination date
- Apr 10, 2013
- Reason for recall
- Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
- Distribution pattern
- Nationwide
- Recall initiation date
- May 2, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2012