Buprenorphine and Naloxone Sublingual Film 2 mg/0.5mg Recall: Subpotent
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
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Buprenorphine recalled?
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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
Which lot codes, UPCs or models are affected?
Lot #: 36924, Exp 6/2021
- Agency record number
- D-0649-2021
- Product
- 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
- Recalling firm
- Alvogen, Inc
- Quantity
- 9,696 cartons
- Distribution
- USA nationwide.
- Recall started
- February 26, 2021
- Report date
- July 14, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)