PAI Holdings, LLC. dba Pharmaceutical Associates Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0222-2025Class IIIGuaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottlesJanuary 7, 2025
D-0721-2021Class IINystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in July 29, 2021
D-0722-2021Class IICimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical AssociJuly 29, 2021
D-0723-2021Class IIEthosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, July 29, 2021
D-0015-2021Class IIICitalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical AsSeptember 9, 2020
D-1494-2020Class IINystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), RAugust 4, 2020
D-1060-2020Class IINystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) botMarch 19, 2020