Teva Pharmaceuticals recalls Fentanyl Buccal Tablets CII 100mcg due to incorrect or missing package inserts. This may lead to improper use. Consumers should contact the manufacturer for details.
Labeling: Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets CII 100mcg because the package insert might be missing or incorrect. This could lead to improper use of the medication, which is dangerous for patients.
The package insert is critical for safe use of this prescription medication. Without it, patients may not understand how to use the tablets correctly, leading to potential misuse or incorrect dosing.
Patients prescribed Fentanyl Buccal Tablets CII 100mcg by a doctor. Those who have the specific lot numbers and expiration dates listed in the recall are most at risk.
Check for the product name 'Fentanyl Buccal Tablets CII 100mcg', lot number 42617828 (expiring 06/2023) or 100020465 (expiring 01/2024). The product is sold in cartons of 28 tablets (4 tablets x 7 cards).
Ensure the package insert is present and correct before using the medication.
The recall is due to a potential missing or incorrect package insert, which could lead to improper use. Consult your doctor or pharmacist for guidance.
The official recall does not specify a remedy, so contact Teva Pharmaceuticals directly for further instructions.
Look for lot number 42617828 (expiring 06/2023) or 100020465 (expiring 01/2024) in the product packaging.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0766-2023 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0766-2023 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
