D-0321-2024 Class III Ongoing
FDA drug recall D-0321-2024 was initiated by Teva Pharmaceuticals USA, Inc on Jan 25, 2024 and is designated Class III. Reason for recall: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. The recall status is ongoing. Affected quantity: 12,916 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2024
- Initiation Date
- Jan 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,916 cartons
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
Reason for Recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Distribution Pattern
nationwide
Code Information
Lot #: 100042978, Exp 7/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0321-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026