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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

Teva Pharmaceuticals USA Inc 2023-05-31 Health moderate FDA
Health · FDA · Recall #FDA-D-0769-2023

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… Recall

Issued May 31, 2023 · Teva Pharmaceuticals USA Inc

In May 2023, Teva Pharmaceuticals USA Inc recalled the Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Labeling: Incorrect or Missing Package Insert

What you should do

  1. 1 Stop using Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Teva Pharmaceuticals USA Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Teva Pharmaceuticals USA Inc
Category
Health
Recall date
May 31, 2023
Units affected
Not reported
Sold at
US Nationwide
Recall number
FDA-D-0769-2023
Made in
United States
Issuing agency
FDA

In context

  • Teva Pharmaceuticals USA Inc has 8 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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