Novis PR, LLC dba Kramer Novis

FDA Regulatory Profile

Novis PR, LLC dba Kramer Novis appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0868-2023, Class I) was initiated on April 20, 2023.

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0868-2023Class IG-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough SuppressanApril 20, 2023
F-0810-2023Class IIGPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12March 27, 2023
F-0812-2023Class IIPreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 unitsMarch 27, 2023
F-0811-2023Class IIPreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units ofMarch 27, 2023
F-0037-2023Class IIIG-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (August 25, 2022