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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