Geritrex Corp

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1525-2019Class IIRitussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial AvenueMay 31, 2019
D-1521-2019Class IIRitussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial AvenMay 31, 2019
D-1520-2019Class IIDiphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical CorporaMay 31, 2019
D-1522-2019Class IIGericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: GericMay 31, 2019
D-1527-2019Class IIPreferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL,May 31, 2019
D-1524-2019Class IIPreferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: GerMay 31, 2019
D-1526-2019Class IIGericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street BrooklyMay 31, 2019
D-1523-2019Class IIGericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-caMay 31, 2019
D-1437-2019Class IISenna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 CommerciaMay 6, 2019
D-1436-2019Class IISenna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 CommeMay 6, 2019
D-0390-2016Class IICarbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 5October 27, 2015
D-0391-2016Class IICarbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, DistributeOctober 27, 2015
D-0392-2016Class IIGRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by GeOctober 27, 2015
D-0393-2016Class IIPolyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9October 27, 2015
D-1238-2015Class IIICarb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx OJune 5, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K945224GRX FOAM DRESSINGApril 3, 1995
K931509GERITREX STERILE SALINE SOLUTION FOR IRRIGATIONSeptember 22, 1994
K931511GERITREX STERILE WATER FOR IRRIGATIONFebruary 14, 1994
K931510GERITREX STERILE SALINE WET DRESSINGJuly 13, 1993