FDA (Drugs) recall action 81646

Teva Pharmaceuticals USA recalled 8 products on 2018-12-19

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-12-19
Critical: 0
Units: 508,220

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific bottles of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMAC
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACE
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
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 PHARMACE
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMA
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets 5 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
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,
Category
Distribution
1 state
SevereFDA (Drugs)··2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales,
Category
Distribution
1 state