D-0024-2023 Class II Terminated
FDA drug recall D-0024-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Oct 18, 2022 and is designated Class II. Reason for recall: Presence of Foreign Substance The recall status is terminated (terminated Sep 7, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 9, 2022
- Initiation Date
- Oct 18, 2022
- Termination Date
- Sep 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Distribution Pattern
Nationwide with the United States
Code Information
Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0024-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026