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Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count ...

FDA Recall #D-0303-2019 — Class II — November 27, 2018

Recall #D-0303-2019 Date: November 27, 2018 Classification: Class II Status: Ongoing

Product Description

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Reason for Recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Recalling Firm

Teva Pharmaceuticals USA — North Wales, PA

Classification

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

Product Type

Drugs

Product Quantity

120,394 bottles

Distribution

USA Nationwide including Puerto Rico.

Code Information

NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024

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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