Valsartan Tablet, Film Coated
FDA Recall NDC 0378-5813

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 8 recorded enforcement report(s) associated with Valsartan (NDC 0378-5813). 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.

Reported Recall Events

D-0326-2019ONGOINGD-0327-2019ONGOINGD-0324-2019ONGOINGD-0325-2019ONGOINGD-0316-2019ONGOINGD-0315-2019ONGOINGD-0313-2019ONGOINGD-0314-2019ONGOING

December 2018 Class II Recall: GCMP Deviations

Recall Number
D-0326-2019
Class II Ongoing
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.
Initiated
Dec 04, 2018
Reported
Dec 19, 2018
Quantity
232,180 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
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

December 2018 Class II Recall: GCMP Deviations

Recall Number
D-0327-2019
Class II Ongoing
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.
Initiated
Dec 04, 2018
Reported
Dec 19, 2018
Quantity
129,754 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
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

December 2018 Class II Recall: GCMP Deviations

Recall Number
D-0324-2019
Class II Ongoing
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.
Initiated
Dec 04, 2018
Reported
Dec 19, 2018
Quantity
160,300 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
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3063780, 3074879, 3086684, 3086687
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

December 2018 Class II Recall: GCMP Deviations

Recall Number
D-0325-2019
Class II Ongoing
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.
Initiated
Dec 04, 2018
Reported
Dec 19, 2018
Quantity
119,761 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
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.
Batch or Lot Expiration Information
Lot# Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

November 2018 Class II Recall: CGMP Deviations

Recall Number
D-0316-2019
Class II Ongoing
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Initiated
Nov 20, 2018
Reported
Dec 19, 2018
Quantity
25,147 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
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.
Batch or Lot Expiration Information
Lot# 3081499, exp. date 3/2020
Lot# 3080009, exp. date 2/2020
Lot# 3080010, exp. date 2/2020
Lot# 3079205, exp. date 1/2020
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

November 2018 Class II Recall: CGMP Deviations

Recall Number
D-0315-2019
Class II Ongoing
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Initiated
Nov 20, 2018
Reported
Dec 19, 2018
Quantity
63,213 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
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
Batch or Lot Expiration Information
Lot# 3061169, exp. date 11/2018
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

November 2018 Class II Recall: CGMP Deviations

Recall Number
D-0313-2019
Class II Ongoing
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Initiated
Nov 20, 2018
Reported
Dec 19, 2018
Quantity
24,709 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
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.
Batch or Lot Expiration Information
Lot# 3063782, exp. date 1/2019
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

November 2018 Class II Recall: CGMP Deviations

Recall Number
D-0314-2019
Class II Ongoing
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Initiated
Nov 20, 2018
Reported
Dec 19, 2018
Quantity
12,840 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
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.
Batch or Lot Expiration Information
Lot# 3071352, exp. date 7/2019
Affected Packages Involved in this Recall
0378-5807-93Product
0378-5813-77Product
0378-5814-77Product
0378-5815-77Product

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.