Fentanyl Buccal Tablets recalled due to missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III FDA recall for a documentation issue—missing or incorrect package inserts—with no reported harm or adverse events.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets CII 100mcg distributed nationwide. The recall affects 438 units across Lot Number 42617828 (expiration 06/2023) and Lot Number 100020465 (expiration 01/2024), packaged in cartons of 28 tablets.
The recall was issued because the affected packages contain incorrect or missing package inserts. Package inserts provide essential information about medication administration, dosing, and safety precautions.
Patients who have packages matching the recalled lot numbers should contact their pharmacy or healthcare provider to obtain the correct package insert or verify their package contains complete labeling information.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 438
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot# 42617828
- Exp 06/2023
- 100020465
- Exp 01/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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