Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister ca
Summary
The FDA issued a Class III for Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in ca by Teva Pharmaceuticals USA, Inc. Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets..
Details
Source
Drug Recall
External ID
D-0321-2024
Action Date
2024-02-21
Status
Ongoing
Category
drug
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/Code Info: Lot #: 100042978, Exp 7/31/2024
Quantity Affected: 12,916 cartons
Reason for Recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Distribution
nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-25
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0321-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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