Why it was recalled
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Product description
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Lot numbers, UPCs & expiration codes
Lot #: 100042978, Exp 7/31/2024
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-0321-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jan 25, 2024
- FDA report date
- Feb 21, 2024
- Quantity
- 12,916 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0321-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93867
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100042978, Exp 7/31/2024
- Postal code
- 07054-1120
- Report date
- Feb 21, 2024
- Product type
- Drugs
- Recall number
- D-0321-2024
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 12,916 cartons
- Reason for recall
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
- Distribution pattern
- nationwide
- Recall initiation date
- Jan 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2024