Reported Apr 5, 2017 · Terminated

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan…

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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 Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201

Is this the product you have?

  • Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only
  • Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Lot codes and dates
    • Lot #: 3084288
    • Exp. 07/18
Amount recalled
1,527 cartons

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

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 Mar 15, 2019 · Data as of Sep 19, 6:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.