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Class II · ModerateRecall completed

Atorvastatin Calcium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 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
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc.
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN CALCIUM TRIHYDRATE
Distributed by / forMylan Pharmaceuticals Inc.
NDC0378-3953-09
Show the full FDA record
Full product labelAtorvastatin 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.
Recalling firmMylan Pharmaceuticals Inc.
DistributionNationwide in the USA and Puerto Rico
Quantity452,269 bottles
Recall initiated2017-03-20
Report date2017-04-05
Recall completed2018-01-26
Recall numberD-0621-2017
ClassificationClass II
FDA statusTerminated
Origin on fileMorgantown WV United States

Related

Atorvastatin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.