Reported Jan 1, 2014 · Terminated

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz…

Sandoz Incorporated

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: Sandoz Incorporated · 2555 W Midway Blvd · Broomfield, CO · 80020-1632

Is this the product you have?

  • Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Lot codes and dates
    • Lots DE9898
    • DE9900
    • DE9903
    • DE9908
    • DE9911. Exp. 06/14
Amount recalled
12,521 bottles

Where it was sold

  • Nationwide

Why it was recalled

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

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 Jul 10, 2014 · Data as of Sep 19, 5:02 PM UTC

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