Novartis Pharmaceuticals Corp.
Novartis Pharmaceuticals Corp. appears in FDA public data with 26 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1174-2023, Class I) was initiated on September 8, 2023.
Summary
- Total Recalls
- 26 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1174-2023 | Class I | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufa | September 8, 2023 |
| D-1309-2019 | Class I | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, | May 11, 2019 |
| D-0678-2017 | Class III | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, | March 22, 2017 |
| D-0679-2017 | Class III | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured | March 22, 2017 |
| D-1430-2015 | Class III | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alk | July 28, 2015 |
| D-1138-2015 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister | May 22, 2015 |
| D-1137-2015 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister | May 22, 2015 |
| D-1516-2014 | Class III | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon | July 30, 2014 |
| D-1387-2014 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, | May 28, 2014 |
| D-1228-2014 | Class III | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pha | March 3, 2014 |
| D-1227-2014 | Class III | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pha | March 3, 2014 |
| D-333-2014 | Class II | Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sampl | August 8, 2013 |
| D-338-2014 | Class II | Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. | August 8, 2013 |
| D-337-2014 | Class II | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. | August 8, 2013 |
| D-332-2014 | Class II | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, | August 8, 2013 |
| D-329-2014 | Class II | Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample | August 8, 2013 |
| D-331-2014 | Class II | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottl | August 8, 2013 |
| D-336-2014 | Class II | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample | August 8, 2013 |
| D-326-2014 | Class II | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, | August 8, 2013 |
| D-328-2014 | Class II | Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample | August 8, 2013 |