PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 9, 2022 Initiated: October 18, 2022 #D-0024-2023

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

Reason for Recall

Presence of Foreign Substance

Details

Units Affected
N/A
Distribution
Nationwide with the United States
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: N/A.
Why was this product recalled?
Presence of Foreign Substance
Which agency issued this recall?
This recall was issued by the FDA Drug on November 9, 2022. Severity: Moderate. Recall number: D-0024-2023.