US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 21, 2017 (9 years ago)

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Atorvastatin 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 firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
NDC code
51079-208-20
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0622-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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