Fentanyl Buccal Tablets CII recall: Labeling Error
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
Why was Fentanyl Buccal Tablets CII recalled?
Labeling: Incorrect or Missing Package Insert
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024
- 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
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Quantity
- 1272
- Distribution
- US Nationwide
- Recall date
- May 31, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)