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
Reported: July 14, 2021 Initiated: February 26, 2021 #D-0649-2021
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
Reason for Recall
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 9,696 cartons
- Distribution
- USA nationwide.
- Location
- Morristown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Alvogen, Inc. Units affected: 9,696 cartons.
Why was this product recalled? ▼
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 14, 2021. Severity: Moderate. Recall number: D-0649-2021.
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