ULTRAtab Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
43
510(k) Clearances
0
Inspections
11
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0532-2022Class IICoated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY January 26, 2022
D-0546-2022Class IICoated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, January 26, 2022
D-0542-2022Class IISpearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., HigJanuary 26, 2022
D-0534-2022Class IICoated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., HighlaJanuary 26, 2022
D-0552-2022Class IILegatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, InJanuary 26, 2022
D-0550-2022Class IIPain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, InJanuary 26, 2022
D-0545-2022Class IIPhenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., HJanuary 26, 2022
D-0540-2022Class IICherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., HighlaJanuary 26, 2022
D-0529-2022Class IIAPAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NYJanuary 26, 2022
D-0539-2022Class IIPeppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., HiJanuary 26, 2022
D-0548-2022Class IIAPAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, IncJanuary 26, 2022
D-0543-2022Class IINutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., January 26, 2022
D-0525-2022Class IIZee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRJanuary 26, 2022
D-0530-2022Class IIAPAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRJanuary 26, 2022
D-0528-2022Class IICoated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk ContainJanuary 26, 2022
D-0536-2022Class IIAPAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY January 26, 2022
D-0541-2022Class IITrial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., HighlanJanuary 26, 2022
D-0538-2022Class IIHPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk ContaiJanuary 26, 2022
D-0547-2022Class IIMigrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., January 26, 2022
D-0549-2022Class IINormed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc.January 26, 2022