FDA Recall D-0330-2019

Mylan Laboratories Limited, (Nashik FDF) · Sinnar, Nashik District, N/A

Class II Ongoing 2718 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lot numbers: 3084887 3093802 3084887 3084888 3093802

Quantity: 22,813 HDPE bottles

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.

Recall record

Recall number: D-0330-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Recall initiated: 2018-12-04
Classified by FDA Center: 2018-12-14
FDA published: 2018-12-19
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Firm location: Sinnar, Nashik District, N/A, India

Drug identification

Brand name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Generic name(s): VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Mylan Pharmaceuticals Inc.
NDC(s): 0378-6321, 0378-6322, 0378-6323, 0378-6324, 0378-6325
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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