October 2022 FDA Recall Buprenorphine And Naloxone by Sun Pharmaceutical Industries Inc
D-0024-2023 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on October 18, 2022 for the product Buprenorphine And Naloxone. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0024-2023

Reason for Recall
Presence of Foreign Substance
Initiated
10-18-2022
Reported
11-09-2022
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91033
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-07-2023
Product Description About Product Description
Full technical description of the product.
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

62756-969-83 Buprenorphine And Naloxone
62756-969-64 Buprenorphine And Naloxone
62756-970-83 Buprenorphine And Naloxone
62756-970-64 Buprenorphine And Naloxone