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

SUN PHARMACEUTICAL INDUSTRIES INC 2024-03-06 Health serious FDA
Health · FDA · Recall #FDA-D-0350-2024

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle,… Recall

Issued March 6, 2024 · SUN PHARMACEUTICAL INDUSTRIES INC

In March 2024, SUN PHARMACEUTICAL INDUSTRIES INC recalled the Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Failed Dissolution Specifications: Out of specification for dissolution.

What you should do

  1. 1 Stop using Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact SUN PHARMACEUTICAL INDUSTRIES 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
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Health
Recall date
March 6, 2024
Units affected
Not reported
Sold at
Nationwide in the U.S.
Recall number
FDA-D-0350-2024
Made in
United States
Issuing agency
FDA

In context

  • SUN PHARMACEUTICAL INDUSTRIES INC has 34 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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