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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 36924, Exp 6/2021
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Alvogen, Inc
- Reason for Recall:
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot #: 36924, Exp 6/2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0649-2021
Related Recalls
Class I - Dangerous
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class I - Dangerous
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class I - Dangerous
Failed dissolution specifications