Buprenorphine Tablet
FDA Recall NDC 62756-460
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buprenorphine (NDC 62756-460). A significant event, classified as Class II, was initiated on May 03, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
May 03, 2023
Jun 14, 2023
12,336 bottles
Recall Profile & Regulatory Data
Event ID
92256
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 19 distributors nationwide.
Termination Date
Jan 09, 2024
Product Description
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Batch or Lot Expiration Information
Lot# : DND1515A, Exp 08/24
Affected Packages Involved in this Recall
62756-459-83Product
62756-459-64Product
62756-460-83Product
62756-460-64Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
