Buprenorphine and Naloxone Sublingual Film 2mg/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
Why was Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled?
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 36924, Exp 6/2021
- 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 date
- July 14, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)