Apri Kit
FDA Recall NDC 0555-9043
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 Apri (NDC 0555-9043). A significant event, classified as Class III, was initiated on Jun 17, 2014 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: out of specification impurity test results."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Jun 17, 2014
Jul 23, 2014
1104 blister packs
Recall Profile & Regulatory Data
Event ID
68610
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 09, 2015
Product Description
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58
Batch or Lot Expiration Information
Lot# Lot 3805324A Exp. 11/14
Affected Packages Involved in this Recall
0555-9043-79Product
0555-9043-58Product
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.
