Recall Enforment Report D-0332-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mylan Laboratories Limited, (Nashik FDF), originally initiated on 12-04-2018 for the product Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. The product was recalled due to gcmp deviations: fda analysis confirmed presence of trace amounts of an impurity, n-nitrosodiethylamine (ndea) found in the api used to manufacture the product.. The product was distributed in Product Was Distributed Throughout The United States To Several Major Distributors, Including Puerto Rico. and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0332-2019	12-04-2018	12-19-2018	Class II	32,284 HDPE bottles	Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0322-2019	12-04-2018	12-19-2018	Class II	109,314 HDPE bottles	Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0326-2019	12-04-2018	12-19-2018	Class II	232,180 HDPE bottles	Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0325-2019	12-04-2018	12-19-2018	Class II	119,761 HDPE bottles	Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0327-2019	12-04-2018	12-19-2018	Class II	129,754 HDPE bottles	Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0324-2019	12-04-2018	12-19-2018	Class II	160,300 HDPE bottles	Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0328-2019	12-04-2018	12-19-2018	Class II	32,696 HDPE bottles	Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0330-2019	12-04-2018	12-19-2018	Class II	22,813 HDPE bottles	Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0321-2019	12-04-2018	12-19-2018	Class II	76,516 HDPE bottles	Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0329-2019	12-04-2018	12-19-2018	Class II	50,595 HDPE bottles	Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0320-2019	12-04-2018	12-19-2018	Class II	141,995 HDPE bottles	Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0331-2019	12-04-2018	12-19-2018	Class II	19,352 HDPE bottles	Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing
D-0323-2019	12-04-2018	12-19-2018	Class II	84,066 HDPE bottles	Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0378-1721	Amlodipine And Valsartan	Amlodipine And Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-1722	Amlodipine And Valsartan	Amlodipine And Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-1723	Amlodipine And Valsartan	Amlodipine And Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-1724	Amlodipine And Valsartan	Amlodipine And Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-5807	Valsartan	Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-5813	Valsartan	Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-5814	Valsartan	Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-5815	Valsartan	Valsartan	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-6321	Valsartan And Hydrochlorothiazide	Valsartan And Hydrochlorothiazide	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-6322	Valsartan And Hydrochlorothiazide	Valsartan And Hydrochlorothiazide	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-6323	Valsartan And Hydrochlorothiazide	Valsartan And Hydrochlorothiazide	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-6324	Valsartan And Hydrochlorothiazide	Valsartan And Hydrochlorothiazide	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug
0378-6325	Valsartan And Hydrochlorothiazide	Valsartan And Hydrochlorothiazide	Tablet, Film Coated	Oral	Mylan Pharmaceuticals Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0332-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	32,284 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863 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	0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0322-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	109,314 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432 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	0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0326-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	232,180 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623 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	0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0325-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	119,761 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710 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	0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0327-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	129,754 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476 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	0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0324-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	160,300 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3063780, 3074879, 3086684, 3086687 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	0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0328-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	32,696 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800 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	0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0330-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	22,813 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 3084887 3093802 3084887 3084888 3093802 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	0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0321-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	76,516 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 3064085, 3066063,3069638,3069639 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	0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0329-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	50,595 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801 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	0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0320-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	141,995 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772 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	0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0331-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	19,352 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot numbers: 3084889 3084890 3093803 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	0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05
Status	Ongoing

Field Name	Field Value
Event ID	81707 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0323-2019 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	Product was distributed throughout the United States to several major distributors, including 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	Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.
Reason For Recall	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	84,066 HDPE 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	12-19-2018
Recall Initiation Date	12-04-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release 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 Laboratories Limited, (Nashik FDF)
Code Info	Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617 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	0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93
Status	Ongoing