Drug Enforcement D-0767-2023

Labeling: Incorrect or Missing Package Insert

Status

Terminated

Classification

Class III

Report Date

May 31, 2023

Termination Date

February 29, 2024

Product Information

Product description
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
Product quantity
397
Reason for recall
Labeling: Incorrect or Missing Package Insert
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA Inc
Address
400 Interpace Pkwy Bldg A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0767-2023
Event ID
92133
Recall initiation date
April 27, 2023
Center classification date
May 24, 2023
Code info
Lot #: 100020528, Exp 09/2024; 100026699, Exp 11/2024
More code info
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