Reported Jun 10, 2015 · Terminated

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown,…

Mylan Lab Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Lab Inc · 1500 Corporate Dr Ste 400 · Canonsburg, PA · 15317-8580

Is this the product you have?

  • Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
Lot codes and dates
    • Lot #: 3059043
    • Exp 08/16
Amount recalled
7,722 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Low out of specification dissolution results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 21, 2016 · Data as of Sep 19, 6:29 PM UTC

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