Recalls / Class II

Class IID-0310-2019

Product

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Affected lot / code info

All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98

Why it was recalled

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

Recalling firm

Firm

Teva Pharmaceuticals USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

31,079 bottles

Distribution pattern

USA Nationwide including Puerto Rico.

Timeline

Recall initiated

2018-11-27

FDA classified

2018-12-14

Posted by FDA

2018-12-19

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0310-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.