BUPRENORPHINE HYDROCHLORIDE Recall D-0024-2023
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
BUPRENORPHINE HYDROCHLORIDE Recall D-0024-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0024-2023 |
| Event ID | 91033 |
| Brand | BUPRENORPHINE AND NALOXONE |
| Generic Name | BUPRENORPHINE AND NALOXONE |
| Manufacturer | BUPRENORPHINE AND NALOXONE |
| Original Package? | 1 |
| Active Substance | BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE DIHYDRATE |
| Drug Route | SUBLINGUAL |
| Distribution | Nationwide with the United States |
| Recall Reason | Presence of Foreign Substance |
| Drug Classification | Class II |
| Drug Code Info | 20221109 |
| Product NDC | 62756-969 62756-970 |
| Drug UPC | 0362756969834 0362756970830 |
| Recall Initiation Date | 20221018 |
| Report Date | 20221109 |
| Classification Date | 20221031 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 56W8MW3EN1 5Q187997EE |
| Drug Application Number | ANDA201633 |
| Structured Product Labeling (SPL ID) | c32f0b15-6b33-48ba-9425-4aa223d08348 |
| Structured Product Labeling (SPL Set ID) | 91b68606-05de-4586-ae31-07e8cc9160cf |
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