Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 0378-3952
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 0378-3952). A significant event, classified as Class II, was initiated on Mar 20, 2017 by Mylan Pharmaceuticals 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 20, 2017
Apr 05, 2017
299,112 bottles
Recall Profile & Regulatory Data
Event ID
76750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 26, 2018
Product Description
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 3073776, Exp 01/18; 3073777, 3074909, Exp 02/18; 3075564, 3075565, Exp 03/18; 2007338, Exp 08/18; b) 3070838, Exp 10/17; 3073775, Exp 01/18; 3074908, 3074909, Exp 02/18; 3075564, Exp 03/18; 2007224, 3075887, Exp 06/18; 2007337, 2007338, Exp 08/18
Affected Packages Involved in this Recall
0378-3950-77Product
0378-3950-05Product
0378-3950-09Product
0378-3950-07Product
0378-3951-77Product
0378-3951-05Product
0378-3951-09Product
0378-3951-07Product
0378-3952-77Product
0378-3952-05Product
0378-3952-09Product
0378-3952-07Product
0378-3953-77Product
0378-3953-05Product
0378-3953-09Product
0378-3953-07Product
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 20, 2017
Apr 05, 2017
1,233,107 bottles
Recall Profile & Regulatory Data
Event ID
76750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 26, 2018
Product Description
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18; b) 3073773, Exp 01/18; 2007445, Exp 09/18; c) 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18; d) 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18
Affected Packages Involved in this Recall
0378-3950-77Product
0378-3950-05Product
0378-3950-09Product
0378-3950-07Product
0378-3951-77Product
0378-3951-05Product
0378-3951-09Product
0378-3951-07Product
0378-3952-77Product
0378-3952-05Product
0378-3952-09Product
0378-3952-07Product
0378-3953-77Product
0378-3953-05Product
0378-3953-09Product
0378-3953-07Product
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 20, 2017
Apr 05, 2017
444,201 bottles
Recall Profile & Regulatory Data
Event ID
76750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 26, 2018
Product Description
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 3073779, 3073780, Exp 02/18; 3074910, Exp 03/18; 3075568, Exp 04/18; 3075889, 3075890, Exp 06/18; 2007339, 2007340, Exp 08/18; 3079881, 3079882, Exp 10/18; b) 3070839, Exp 10/17; 3073778, 3073779, Exp 02/18; 3075566, 3075567, Exp 04/18; 3075890, 2007225, Exp 06/18; 2007340, Exp 08/18; 3079880, 3079881, Exp 10/18
Affected Packages Involved in this Recall
0378-3950-77Product
0378-3950-05Product
0378-3950-09Product
0378-3950-07Product
0378-3951-77Product
0378-3951-05Product
0378-3951-09Product
0378-3951-07Product
0378-3952-77Product
0378-3952-05Product
0378-3952-09Product
0378-3952-07Product
0378-3953-77Product
0378-3953-05Product
0378-3953-09Product
0378-3953-07Product
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 20, 2017
Apr 05, 2017
452,269 bottles
Recall Profile & Regulatory Data
Event ID
76750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 26, 2018
Product Description
Atorvastatin 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.
Batch or Lot Expiration Information
Lot# : 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
Affected Packages Involved in this Recall
0378-3950-77Product
0378-3950-05Product
0378-3950-09Product
0378-3950-07Product
0378-3951-77Product
0378-3951-05Product
0378-3951-09Product
0378-3951-07Product
0378-3952-77Product
0378-3952-05Product
0378-3952-09Product
0378-3952-07Product
0378-3953-77Product
0378-3953-05Product
0378-3953-09Product
0378-3953-07Product
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.
