Amlodipine And Valsartan Tablet, Film Coated
FDA Recall NDC 0378-1721
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 7 recorded enforcement report(s) associated with Amlodipine And Valsartan (NDC 0378-1721). A significant event, classified as Class II, was initiated on Dec 04, 2018 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 04, 2018
Dec 19, 2018
76,516 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
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.
Batch or Lot Expiration Information
Lot# Lot numbers: 3064085, 3066063,3069638,3069639
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 04, 2018
Dec 19, 2018
109,314 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 04, 2018
Dec 19, 2018
141,995 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
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.
Batch or Lot Expiration Information
Lot# Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 04, 2018
Dec 19, 2018
84,066 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Nov 20, 2018
Dec 19, 2018
23,478 bottles
Recall Profile & Regulatory Data
Event ID
81613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.
Batch or Lot Expiration Information
Lot# 3066051, exp. date 3/2019
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Nov 20, 2018
Dec 19, 2018
48,302 bottles
Recall Profile & Regulatory Data
Event ID
81613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Batch or Lot Expiration Information
Lot# 3061986, exp. date 11/2018
Lot# 3079709, exp. date 1/2020
Lot# 3077618, exp. date 11/2019
Lot# 3079708, exp. date 1/2020
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
Class II Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Nov 20, 2018
Dec 19, 2018
12,336 bottles
Recall Profile & Regulatory Data
Event ID
81613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
Batch or Lot Expiration Information
Lot# 3079500, exp. date 1/2020
Affected Packages Involved in this Recall
0378-1721-93Product
0378-1722-93Product
0378-1723-93Product
0378-1724-93Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
