Novartis Pharmaceuticals Corp.

FDA Regulatory Profile

Summary

Total Recalls
26 (2 Class I)
510(k) Clearances
0
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1174-2023Class ISANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, ManufaSeptember 8, 2023
D-1309-2019Class IPromacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, May 11, 2019
D-0679-2017Class IIIPilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured March 22, 2017
D-0678-2017Class IIIIsopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only,March 22, 2017
D-1430-2015Class IIIDexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by AlkJuly 28, 2015
D-1137-2015Class IIIForadil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister May 22, 2015
D-1138-2015Class IIIForadil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister May 22, 2015
D-1516-2014Class IIICataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: PatheonJuly 30, 2014
D-1387-2014Class IIIForadil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only,May 28, 2014
D-1228-2014Class IIIRitalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis PhaMarch 3, 2014
D-1227-2014Class IIIRitalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis PhaMarch 3, 2014
D-337-2014Class IITekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. August 8, 2013
D-336-2014Class IIStalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician SampleAugust 8, 2013
D-331-2014Class IIExforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottlAugust 8, 2013
D-332-2014Class IIExforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle,August 8, 2013
D-340-2014Class IITekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician August 8, 2013
D-339-2014Class IITekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, PhysiciaAugust 8, 2013
D-330-2014Class IIExforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottleAugust 8, 2013
D-333-2014Class IIExforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician SamplAugust 8, 2013
D-327-2014Class IIDiovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, August 8, 2013