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- Recall Enforcement Event ID: 81707
Recall Enforment Report D-0326-2019
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 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. 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-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-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-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-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-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-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-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-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 |
Recall Enforcement Report D-0326-2019
- 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
Recall Enforcement Report D-0327-2019
- 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
Recall Enforcement Report D-0325-2019
- 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
Recall Enforcement Report D-0324-2019
- 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
Recall Enforcement Report D-0328-2019
- 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
Recall Enforcement Report D-0332-2019
- 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
Recall Enforcement Report D-0330-2019
- 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
Recall Enforcement Report D-0321-2019
- 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
Recall Enforcement Report D-0322-2019
- 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
Recall Enforcement Report D-0329-2019
- 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
Recall Enforcement Report D-0320-2019
- 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
Recall Enforcement Report D-0331-2019
- 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
Recall Enforcement Report D-0323-2019
- 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
