Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Summary
The FDA issued a Class III for Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 by Teva Pharmaceuticals USA Inc. Reason: Labeling: Incorrect or Missing Package Insert.
Details
Source
Drug Recall
External ID
D-0766-2023
Action Date
2023-05-31
Status
Terminated
Category
drug
Product Description
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Lot/Code Info: Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024
Quantity Affected: 438
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-27
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 216 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0766-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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