Buprenorphine Hydrochloride Injection
FDA Recall NDC 0143-9246
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 Hydrochloride (NDC 0143-9246). A significant event, classified as Class II, was initiated on Aug 14, 2020 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing."
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
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Aug 14, 2020
Sep 02, 2020
97,890 vials
Recall Profile & Regulatory Data
Event ID
86243
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jun 10, 2021
Product Description
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Batch or Lot Expiration Information
Lot# s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Affected Packages Involved in this Recall
0143-9246-01Product
0143-9246-05Product
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.
