FDA-Drug2023-05-31Class III
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Teva Pharmaceuticals USA Inc
Hazard
Labeling: Incorrect or Missing Package Insert
Sold states
US Nationwide
Affected count
3032
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0770-2023Don't want to check this manually?
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