Option 2 Tablet
FDA Recall NDC 0113-2003
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 Option 2 (NDC 0113-2003). A significant event, classified as Class II, was initiated on Jun 01, 2017 by L. Perrigo Company. The reported reason for this action was: "Defective Container: Carton is missing the tablet blister strip and tablet."
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 II Terminated
Defective Container: Carton is missing the tablet blister strip and tablet.
Jun 01, 2017
Jun 14, 2017
181,776 (units/eaches)
Recall Profile & Regulatory Data
Event ID
77397
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
L. Perrigo Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Canada
Termination Date
Nov 21, 2017
Product Description
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
Batch or Lot Expiration Information
Lot# : 6LV1114, 6LV1115, 6LV1116, 6MV0976, 6MV0977, Exp.04/18; 7AV1173, 7AV1175, 7AV1176, Exp.07/18.
Affected Packages Involved in this Recall
0113-2003-12Product
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.
