Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 51079-211
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 51079-211). A significant event, classified as Class II, was initiated on Mar 21, 2017 by Mylan Institutional Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2017 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Mar 21, 2017
Apr 05, 2017
1,527 cartons
Recall Profile & Regulatory Data
Event ID
76802
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 15, 2019
Product Description
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
Batch or Lot Expiration Information
Lot# : 3084288, Exp. 07/18
Affected Packages Involved in this Recall
51079-208-01Product
51079-208-20Product
51079-209-01Product
51079-209-20Product
51079-210-01Product
51079-210-20Product
51079-211-01Product
51079-211-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
