FDA Drug Low Class III Terminated

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

Reported: May 31, 2023 Initiated: April 27, 2023 #D-0768-2023

Product Description

Reason for Recall

Labeling: Incorrect or Missing Package Insert

Details

Recalling Firm: Teva Pharmaceuticals USA Inc
Units Affected: 1272
Distribution: US Nationwide
Location: Parsippany, NJ

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 1272.

Why was this product recalled? ▼

Labeling: Incorrect or Missing Package Insert

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 31, 2023. Severity: Low. Recall number: D-0768-2023.