Sandoz Incorporated

FDA Regulatory Profile

Summary

Total Recalls
16 (1 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0631-2018Class IIITriamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, ManufactuApril 6, 2018
D-0943-2017Class IIIAmitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000June 16, 2017
D-0236-2017Class IINadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., PriDecember 22, 2016
D-0291-2015Class IIIFluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08December 5, 2014
D-1509-2014Class IIAlprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061July 25, 2014
D-383-2014Class IITacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz PrivOctober 22, 2013
D-66373-001Class IIIHydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., PrincSeptember 25, 2013
D-854-2013Class IIIIntrovale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day rAugust 7, 2013
D-805-2013Class IIEstarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per cartonJune 21, 2013
D-597-2013Class IICefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, ManufactMay 30, 2013
D-832-2013Class IMethotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx onlMay 20, 2013
D-268-2013Class IIAmoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, April 18, 2013
D-152-2013Class IIISyeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination orJanuary 22, 2013
D-008-2013Class IIIChildren's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by SanSeptember 20, 2012
D-1678-2012Class IIIPramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured inSeptember 12, 2012
D-1677-2012Class IIIPramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in September 12, 2012