Teva Pharmaceuticals recalls Fentanyl Buccal Tablets (600mcg) due to missing or incorrect package inserts. This could lead to improper use. Affected units include specific lots from Mayne Pharma.
Labeling: Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (600mcg) because the package insert may be missing or incorrect. This could lead to improper use of the medication, which is dangerous for patients.
The missing or incorrect package insert means patients may not receive clear instructions on how to use the medication safely. This could lead to improper administration, which is especially risky for a potent opioid.
Patients prescribed Fentanyl Buccal Tablets by a doctor are affected. Those using the medication without proper instructions are at higher risk.
Check for the specific lot numbers: 42617831 (expiring June 2023), 42619585 (expiring November 2023), and 100029649 (expiring November 2024). The product is sold in cartons of 28 tablets (4 tablets per card, 7 cards).
Ensure the package insert is present and correct before using the medication.
The recall is due to missing or incorrect package inserts, which could lead to improper use. However, the official notice does not specify the exact risk level beyond this.
Check for the lot numbers: 42617831 (expiring June 2023), 42619585 (expiring November 2023), or 100029649 (expiring November 2024). The product is sold in cartons of 28 tablets (4 tablets per card, 7 cards).
The official notice does not specify a remedy for this recall. Check the package insert to ensure it is present and correct before use.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0769-2023 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0769-2023 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.
