FDAFDA · Food and drugs·Recall number D-0770-2023
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
Published May 31, 2023 · Recall initiated: April 27, 2023
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
Labeling: Incorrect or Missing Package Insert
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Distributor
- US Nationwide
- Lot
- Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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