D-0305-2019 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- November 27, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75,883 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Distribution Pattern
USA Nationwide including Puerto Rico.
Code Information
NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037