Reported Dec 5, 2012 · Terminated

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC…

Mylan LLC.

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 LLC. · Road #156, Km. 58.8, Lot 24B · Caguas, PR · 00725

Is this the product you have?

  • Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Lot codes and dates
  • Lots
    • 3027684 Exp. 5/13
    • 3027688 Exp. 6/13 2002157 Exp. 9/12
Amount recalled
15181 bottles.

Why it was recalled

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

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 Apr 13, 2017 · Data as of Sep 19, 7:19 PM UTC

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