Buprenorphine And Naloxone Film
FDA Recall NDC 47781-355
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 Buprenorphine And Naloxone (NDC 47781-355). A significant event, classified as Class II, was initiated on Feb 26, 2021 by Alvogen Inc.. The reported reason for this action was: "Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)"
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
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Feb 26, 2021
Jul 14, 2021
9,696 cartons
Recall Profile & Regulatory Data
Event ID
87372
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Feb 16, 2022
Product Description
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Batch or Lot Expiration Information
Lot# : 36924, Exp 6/2021
Affected Packages Involved in this Recall
47781-355-11Product
47781-355-03Product
47781-356-11Product
47781-356-03Product
47781-357-11Product
47781-357-03Product
47781-358-11Product
47781-358-03Product
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.
