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Class III Recall
Teva Pharmaceuticals USA Inc
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
Reason
Labeling: Incorrect or Missing Package Insert
Classification
Class III
Status
Terminated
Lot
Lot#: 42617831, Exp 06/2023; 42619585, Exp 11/2023; 100029649, Exp 11/2024
Date
2023-05-31
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.