Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for a documentation issue—missing or incorrect package insert. No illnesses, injuries, or deaths have been reported. The hazard is informational rather than involving product contamination or active ingredient defects.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets CII, 200mcg, distributed by Mayne Pharma in Greenville, North Carolina. The recall is for certain product lots where the package insert is missing or incorrect.
The recall affects product with the following lot numbers: 100020528 (expires September 2024) and 100026699 (expires November 2024). The product has been distributed nationwide.
Patients currently taking or in possession of affected product should contact their pharmacist or healthcare provider. The product should be returned to the pharmacy for proper handling.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 397
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 #: 100020528
- Exp 09/2024
- 100026699
- Exp 11/2024
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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