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Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufa...

FDA Recall #D-0321-2019 — Class II — December 4, 2018

Recall #D-0321-2019 Date: December 4, 2018 Classification: Class II Status: Ongoing

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.

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.

Recalling Firm

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

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

76,516 HDPE bottles

Distribution

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

Code Information

Lot numbers: 3064085, 3066063,3069638,3069639

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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