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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 #: 3084288, Exp. 07/18
Where it was soldNationwide in the USA
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., Morgantown, WV 26505 U.S.A
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN CALCIUM TRIHYDRATE
Distributed by / forMylan Institutional, Inc. (d.b.a. UDL Laboratories)
NDC51079-208-20
Show the full FDA record
Full product labelAtorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DistributionNationwide in the USA
Quantity1,527 cartons
Recall initiated2017-03-21
Report date2017-04-05
Recall completed2019-03-15
Recall numberD-0622-2017
ClassificationClass II
FDA statusTerminated
Origin on fileRockford IL 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.