FDA Recall D-0321-2019

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

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.

Lot / code: Lot numbers: 3064085, 3066063,3069638,3069639

Quantity: 76,516 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-0321-2019
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): AMLODIPINE AND VALSARTAN
Generic name(s): AMLODIPINE AND VALSARTAN
Manufacturer(s): Mylan Pharmaceuticals Inc.
NDC(s): 0378-1721, 0378-1722, 0378-1723, 0378-1724
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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