Buprenorphine And Naloxone Tablet
FDA Recall NDC 62756-970
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 62756-970). A significant event, classified as Class II, was initiated on Oct 18, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of Foreign Substance"
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
Presence of Foreign Substance
Oct 18, 2022
Nov 09, 2022
N/A
Recall Profile & Regulatory Data
Event ID
91033
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the United States
Termination Date
Sep 07, 2023
Product Description
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
Batch or Lot Expiration Information
Lot# : DNC1129A, Exp 06/2023
Lot# : DNC1740A, Exp 09/2023
Affected Packages Involved in this Recall
62756-969-83Product
62756-969-64Product
62756-970-83Product
62756-970-64Product
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.
