Home / Recalls / Teva Pharmaceuticals USA Inc / D-0766-2023

D-0766-2023 Class III Terminated

Recalled by Teva Pharmaceuticals USA Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
May 31, 2023
Initiation Date
April 27, 2023
Termination Date
February 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
438

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

Reason for Recall

Labeling: Incorrect or Missing Package Insert

Distribution Pattern

US Nationwide

Code Information

Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024

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  • D-0473-2026 Class II — Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems (March 19, 2026)
  • D-0405-2026 Class II — Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 (March 17, 2026)
  • D-0404-2026 Class II — Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 (March 17, 2026)
  • D-0406-2026 Class II — Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 (March 17, 2026)
  • D-0356-2026 Class II — Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bott (January 29, 2026)
  • D-0355-2026 Class II — Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: (January 29, 2026)
  • D-0354-2026 Class II — Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: (January 29, 2026)
  • D-0357-2026 Class II — Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx O (January 29, 2026)