Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024
- 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:
- Teva Pharmaceuticals USA Inc
- Reason for Recall:
- Labeling: Incorrect or Missing Package Insert
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Product Codes/Lot Numbers:
Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0770-2023
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