PAI Holdings, LLC. dba Pharmaceutical Associates recalls
FDA enforcement reports naming PAI Holdings, LLC. dba Pharmaceutical Associates Inc as the recalling firm.
- Recall reports
- 7
- Class I (serious)
- 0
- Most recent report
- Feb 12, 2025
- Feb 12, 2025Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (47…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncSuperpotent; sodium benzoate preservativeClass III
- Aug 18, 2021Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY,…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncLack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.Class II
- Aug 18, 2021Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmace…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncLack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.Class II
- Aug 18, 2021Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncLack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.Class II
- Oct 14, 2020Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Phar…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncFailed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepointClass III
- Aug 19, 2020Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 flDrug · PAI Holdings, LLC. dba Pharmaceutical Associates IncSubpotent drug: Out of specification for assay at the 15-month test interval.Class II
- Apr 1, 2020Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz…Drug · PAI Holdings, LLC. dba Pharmaceutical Associates IncSubPotent Drug: Low out-of-specification results for assay testing.Class II