Recall: D-0024-2023

Class II - Potentially Harmful

Class IIClassification

2022-10-18Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Presence of Foreign Substance

Distribution

Nationwide with the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.