Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0768-2023·Announced 2023-05-31

Fentanyl Buccal Tablets 400mcg missing or incorrect package insert

Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: FDA Class III recall for a labeling/documentation defect (missing or incorrect package insert) with no reported illnesses or injuries. The hazard is documentation-based rather than product contamination or efficacy failure.

Plain-English summary

Teva Pharmaceuticals USA Inc is recalling specific lots of Fentanyl Buccal Tablets, 400mcg (NDC 51862-636-28), distributed by Mayne Pharma. The recall affects 1,272 cartons distributed nationwide. The recall is due to incorrect or missing package inserts in the affected cartons.

Fentanyl Buccal Tablets are controlled substances used for pain management. Proper labeling and package inserts are important for safe medication use and administration.

Patients currently using affected cartons should contact their pharmacy or healthcare provider. Healthcare providers and pharmacies should identify affected lots using the lot numbers and expiration dates and quarantine affected product: Lot 100020351 (Exp 11/2024), Lot 100020522 (Exp 09/2024), and Lot 100026700 (Exp 11/2024). No illnesses or adverse events have been reported in connection with this recall.

The recalled product

Product: Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Manufacturer: Teva Pharmaceuticals USA Inc
Category: Drug — Controlled Substance
Hazard: missing-package-insert
Affected units: 1,272

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 (5)

Lot#: 100020351
Exp 11/2024
100020522
Exp 09/2024
100026700

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.

See all 5 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA Inc

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