Recalls / Class II

Class IID-0305-2019

Product

Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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

NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037

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

75,883 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-0305-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.