FDAFDA · Food and drugs·Recall number D-0649-2021
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
Published July 14, 2021 · Recall initiated: February 26, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE AND NALOXONE
- Manufacturer
- Alvogen, Inc
- Distributor
- USA nationwide.
- UPC
- 0347781356118
- Lot
- Lot #: 36924, Exp 6/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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