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Serious recall: Injury is possible or has been reported. Take action promptly.

Teva Pharmaceuticals USA, Inc 2024-04-17 Health serious FDA
Health · FDA · Recall #FDA-D-0439-2024

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, … Recall

Issued April 17, 2024 · Teva Pharmaceuticals USA, Inc

In April 2024, Teva Pharmaceuticals USA, Inc recalled the Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, …, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

What you should do

  1. 1 Stop using Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, … 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
April 17, 2024
Units affected
Not reported
Sold at
Nationwide in the USA
Recall number
FDA-D-0439-2024
Made in
United States
Issuing agency
FDA

In context

  • Teva Pharmaceuticals USA, Inc has 13 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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