FDA Recall D-0314-2019

Mylan Pharmaceuticals Inc. · Morgantown, WV

Class II Ongoing 2732 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 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.

Lot / code: Lot # 3071352, exp. date 7/2019

Quantity: 12,840 bottles

Reason for recall

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Recall record

Recall number: D-0314-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed throughout the United States.
Recall initiated: 2018-11-20
Classified by FDA Center: 2018-12-14
FDA published: 2018-12-19
Recalling firm: Mylan Pharmaceuticals Inc.
Firm location: Morgantown, WV

Drug identification

Brand name(s): VALSARTAN
Generic name(s): VALSARTAN
Manufacturer(s): Mylan Pharmaceuticals Inc.
NDC(s): 0378-5807, 0378-5813, 0378-5814, 0378-5815
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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