Recalls / Class III
Class IIID-0321-2024
Product
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
- Brand name
- Nortrel
- Generic name
- Norethindrone And Ethinyl Estradiol
- NDCs
- 0555-9008, 0555-9009, 0555-9010
- FDA application
- ANDA072695
- Affected lot / code info
- Lot #: 100042978, Exp 7/31/2024
Why it was recalled
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 12,916 cartons
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2024-01-25
- FDA classified
- 2024-02-12
- Posted by FDA
- 2024-02-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0321-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.