FDA (Drugs) recall action 80847

Torrent Pharma Inc. recalled 12 products on 2018-09-05

The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.

Products: 12
Announced: 2018-09-05
Critical: 0
Units: 634,092

Why these products were recalled

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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.

1–12 of 12

SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 80mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 320mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 160mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
Category
Distribution
0 states
SevereFDA (Drugs)··2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
Category
Distribution
0 states