Class II
Ongoing
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- November 27, 2018
- Posted
- December 19, 2018
- Recall Number
- D-0310-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,079 bottles
- Firm Location
- North Wales, PA, United States
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Distribution
USA Nationwide including Puerto Rico.
Lot / Code Info
All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
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