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

Atorvastatin Calcium Tablets

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.

Other Atorvastatin recalls

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Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-514-90 D-0020-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-512-90 D-0019-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-513-90 D-0018-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-511-90 D-0017-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP 40 mg

Reason Failed dissolution specifications: lower than specifications

Biocon Pharma INC NDC 70377-079-13 D-0306-2025