Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for a documentation issue (missing or incorrect package insert) with no reported illnesses or injuries. Documentation issues are classified as low-severity per the recall rubric.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets CII, 600mcg, because some packages contain incorrect or missing package inserts. The affected product was distributed nationwide with NDC number 51862-637-28.
The recall involves 1,908 units from specific lots: Lot 42617831 (expiration 06/2023), Lot 42619585 (expiration 11/2023), and Lot 100029649 (expiration 11/2024). Distribution was through Mayne Pharma in Greenville, North Carolina.
This is a prescription medication. Patients and healthcare providers who have received this product should contact their pharmacist or Teva Pharmaceuticals for guidance regarding the missing or incorrect package insert.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 1,908
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 (6)
- Lot#: 42617831
- Exp 06/2023
- 42619585
- Exp 11/2023
- 100029649
- 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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