Recalls / Class II

Class IID-0985-2018

Product

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.

Affected lot / code info

Lot Numbers: 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M

Why it was recalled

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Recalling firm

Firm

Teva Pharmaceuticals USA

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505

Distribution

Quantity

164,922 bottles

Distribution pattern

Product was distributed throughout the United States, including Hawaii and Puerto Rico

Timeline

Recall initiated

2018-07-16

FDA classified

2018-07-24

Posted by FDA

2018-08-01

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0985-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.