Reported Apr 5, 2017 · Terminated

Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC…

Mylan Pharmaceuticals 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 Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730

Is this the product you have?

  • Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Lot codes and dates
    • Lot #: a) 3073782
    • 3073783
    • Exp 02/18
    • 3074915
    • 3074916
    • 3074917
    • Exp 03/18
    • 3074918
    • 3075572
    • Exp 04/18
    • 3075573
    • 3075574
    • Exp 05/18
    • 2007226
    • 3075894
    • Exp 06/18
    • 2007344
    • 2007345
    • 2007346
    • Exp 08/18
    • 2007451
    • 2007452
    • 2007453
    • 2007454
    • Exp 09/18
    • b) 3070840
    • Exp 10/17
    • 3073781
    • 3074911
    • Exp 02/18
    • 3074912
    • 3074913
    • 3074914
    • Exp 03/18
    • 3075570
    • 3075571
    • Exp 04/18
    • 3075892
    • Exp 05/18
    • 3075893
    • Exp 06/18
    • 2007341
    • 2007342
    • 2007343
    • 2007347
    • Exp 08/18
    • 2007456
    • Exp 10/18
Amount recalled
452,269 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

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 Jan 26, 2018 · Data as of Sep 19, 5:00 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.