Nortrel 7/7/7 Kit
FDA Recall NDC 0555-9012
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nortrel 7/7/7 (NDC 0555-9012). A significant event, classified as Class III, was initiated on Jan 25, 2024 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Jan 25, 2024
Feb 21, 2024
19,824 cartons
Recall Profile & Regulatory Data
Event ID
93867
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Product Description
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Batch or Lot Expiration Information
Lot# : 100040731, Exp 7/31/2024
Affected Packages Involved in this Recall
0555-9012-79Product
0555-9012-58Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
