FDA (Drugs) recall action 66015

Novartis Pharmaceuticals Corp. recalled 15 products on 2013-12-18

The FDA (Drugs) publishes a recall like this one as 15 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 15 pages.

Products: 15
Announced: 2013-12-18
Critical: 0
Units: 5,315,155

Why these products were recalled

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

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

1–15 of 15

ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Tekturna Tablets Due to Chemical Contamination
Novartis is recalling Tekturna physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.
Product
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several blood pressure medications due to contamination with a photocuring agent found in packaging inks.
Product
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.
Product
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several blood pressure and cholesterol medications due to contamination with a photocuring agent used in packaging inks.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination
Novartis is recalling physician sample bottles of Tekturna HCT and other medications due to contamination with Darocur 1173, a photo-curing agent.
Product
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , ND
Category
Distribution
1 state
SevereFDA (Drugs)··2013-12-18
Novartis Recalls Lescol XL Tablets Due to Chemical Contamination
Novartis is recalling Lescol XL tablets contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.
Product
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936,
Category
Distribution
1 state
HighFDA (Drugs)··2013-12-18
Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Tekturna HCT physician sample bottles due to contamination with Darocur 1173, a photo curing agent used in ink.
Product
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent used in ink.
Product
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.
Product
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
Category
Distribution
1 state
SevereFDA (Drugs)··2013-12-18
Novartis Recalls Exforge HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge HCT physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Physician Sample Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription medications, including Tekturna, due to contamination with a photocuring agent.
Product
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
Category
Distribution
1 state
SevereFDA (Drugs)··2013-12-18
Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription tablets, including Diovan, due to contamination with a photocuring agent.
Product
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of Diovan and other tablets because they were contaminated with Darocur 1173, a photocuring agent used in inks.
Product
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07
Category
Distribution
1 state
SevereFDA (Drugs)··2013-12-18
Novartis Recalls Stalevo Tablets Due to Chemical Contamination
Novartis is recalling Stalevo physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.
Product
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078
Category
Distribution
1 state
ModerateFDA (Drugs)··2013-12-18
Novartis Recalls Multiple Prescription Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription medications due to contamination with a photocuring agent found in ink.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, ND
Category
Distribution
1 state