Altavera Kit
FDA Recall NDC 70700-116
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 Altavera (NDC 70700-116). A significant event, classified as Class III, was initiated on Sep 18, 2018 by Xiromed, Llc.. The reported reason for this action was: "Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion."
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
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Sep 18, 2018
Oct 17, 2018
40064 3x28 units
Recall Profile & Regulatory Data
Event ID
81044
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Xiromed LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 26, 2019
Product Description
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)
Batch or Lot Expiration Information
Lot# Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Affected Packages Involved in this Recall
70700-116-85Product
70700-116-84Product
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.
