ULTRAtab Laboratories, Inc.

FDA Regulatory Profile

ULTRAtab Laboratories, Inc. appears in FDA public data with 43 recalls, 0 510(k) clearances, 11 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0545-2022, Class II) was initiated on January 26, 2022.

Summary

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

Recent Recalls

NumberClassProductDate
D-0545-2022Class IIPhenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., HJanuary 26, 2022
D-0534-2022Class IICoated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., HighlaJanuary 26, 2022
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-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-0530-2022Class IIAPAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRJanuary 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-0539-2022Class IIPeppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., HiJanuary 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
D-0524-2022Class II4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, PhenylepJanuary 26, 2022
D-0548-2022Class IIAPAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, IncJanuary 26, 2022
D-0527-2022Class IIDologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtaJanuary 26, 2022
D-0525-2022Class IIZee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRJanuary 26, 2022
D-0536-2022Class IIAPAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY January 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-0535-2022Class IIExtra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., January 26, 2022
D-0526-2022Class IIKramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mgJanuary 26, 2022