Reported Apr 5, 2017 · Terminated

Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-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?

4 of 4 products

Products covered by this recall
#Product as published
190-count bottles (NDC 0378-3950-77)
290-count bottles (NDC 0378-3950-09)
3500-count bottles (NDC 0378-3950-05)
4500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
13076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18
23073773, Exp 01/18; 2007445, Exp 09/18
33076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18
43070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18
Amount recalled
1,233,107 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, 7:13 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.