Portia Kit
FDA Recall NDC 0555-9020
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 Portia (NDC 0555-9020). A significant event, classified as Class III, was initiated on Mar 12, 2013 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance."
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 Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Mar 12, 2013
Apr 17, 2013
17,661 blister cards
Recall Profile & Regulatory Data
Event ID
64607
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 15, 2014
Product Description
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.
Batch or Lot Expiration Information
Lot# : 33801951A, and 33802189A, Exp 03/13
Affected Packages Involved in this Recall
0555-9020-79Product
0555-9020-58Product
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.
