Recall Enforment Report D-0619-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mylan Pharmaceuticals Inc., originally initiated on 03-20-2017 for the product 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. The product was recalled due to microbial contamination of non-sterile products: potential of an elevated bioburden with identification of objectionable organisms.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0619-2017	03-20-2017	04-05-2017	Class II	299,112 bottles	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.	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.	Terminated
D-0618-2017	03-20-2017	04-05-2017	Class II	1,233,107 bottles	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.	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.	Terminated
D-0620-2017	03-20-2017	04-05-2017	Class II	444,201 bottles	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.	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.	Terminated
D-0621-2017	03-20-2017	04-05-2017	Class II	452,269 bottles	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.	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0378-3950	Atorvastatin Calcium	Atorvastatin Calcium	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-3951	Atorvastatin Calcium	Atorvastatin Calcium	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-3952	Atorvastatin Calcium	Atorvastatin Calcium	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-3953	Atorvastatin Calcium	Atorvastatin Calcium	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	76750 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0619-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	299,112 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	04-05-2017
Recall Initiation Date	03-20-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-26-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Mylan Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	76750 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0618-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,233,107 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	04-05-2017
Recall Initiation Date	03-20-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-26-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Mylan Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	76750 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0620-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	444,201 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	04-05-2017
Recall Initiation Date	03-20-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-26-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Mylan Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	76750 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0621-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	452,269 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	04-05-2017
Recall Initiation Date	03-20-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-26-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Mylan Pharmaceuticals Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.