Teva Pharmaceuticals recalls Fentanyl Buccal Tablets CII 400mcg due to missing or incorrect package inserts. This may affect safe use of the medication. Consumers should contact the manufacturer for details.
Labeling: Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets CII 400mcg because the package insert may be missing or incorrect. This could lead to improper use of the medication, especially since it's a controlled substance requiring precise instructions.
The package insert is critical for safe use of fentanyl, a potent opioid. Without it, users may not understand proper dosing or administration, leading to potential overdose or other serious health issues.
People who have the specific Fentanyl Buccal Tablets CII 400mcg with the listed lot numbers and expiration dates are affected. Those using the medication for pain management are at risk if they don't have the correct package insert.
Check for the specific lot numbers: 100020351 (exp 11/2024), 100020522 (exp 09/2024), or 100026700 (exp 11/2024). The product is a prescription-only medication sold in cartons of 28 tablets.
Verify if the package insert is present and correct for your specific lot number.
The recall states there is a risk of missing or incorrect package inserts, which could lead to improper use. However, the official notice does not specify if this causes immediate danger without the insert.
Look for lot numbers 100020351 (exp 11/2024), 100020522 (exp 09/2024), or 100026700 (exp 11/2024) on the carton.
The recall does not specify a remedy, so contact Teva Pharmaceuticals directly for guidance.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0768-2023 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0768-2023 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.
