Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Drug Recall
Official source record
- Recall number
- D-0649-2021
- Event ID
- 87372
- Classification
- Class II
- Status
- Terminated
- Recalling company
- Alvogen, Inc
- Reason for recall
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Report date
- July 14, 2021
- Recall initiation date
- February 26, 2021
- Termination date
- February 16, 2022
- Distribution pattern
- USA nationwide.
Drug product identifiers
- Manufacturer
- Alvogen Inc.
- Brand name
- BUPRENORPHINE AND NALOXONE
- Generic name
- BUPRENORPHINE AND NALOXONE
- Substance names
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Product NDCs
- 47781-355; 47781-356; 47781-357; 47781-358
- Package NDCs
- 47781-355-03; 47781-355-11; 47781-356-03; 47781-356-11; 47781-357-03; 47781-357-11; 47781-358-03; 47781-358-11
- Routes
- BUCCAL; SUBLINGUAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
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Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record for what each classification level means.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Official guidance and record verification
Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.
How to interpret this historical record
This record is preserved as published by FDA, as of February 16, 2022.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.