Drug 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
D-0024-2023
Product summary
- Event
- Event 91033
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0024-2023
Official wording
Reason: Presence of Foreign Substance
Code information: Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance