FDA recall D-0024-2023

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

Reason for recall

Presence of Foreign Substance

Distribution

Nationwide with the United States

Key facts

Status

Terminated

Initiation date

2022-10-18

Report date

2022-11-09

Termination date

2023-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0024-2023