PAI Holdings, LLC. dba Pharmaceutical Associates Inc Recalls

All product recalls associated with PAI Holdings, LLC. dba Pharmaceutical Associates Inc.

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

0

Most Recent

Jan 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–10 of 10 recalls

Guaifenesin Codeine Solution (PAI Holdings) – Superpotent Preservative (2025)

Superpotent; sodium benzoate preservative

Class IIILow

FDAJan 7, 2025OH• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Ethosuximide Oral Solution (PAI Holdings) – CGMP Violation (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Cimetidine Hydrochloride (PAI Holdings) – CGMP Violation (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class II

Moderate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nystatin Oral Suspension (PAI) – Potential Senna Carryover (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Class IIILow

FDASep 9, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nystatin Oral Suspension (PAI Holdings) – subpotent medication (2020)

Subpotent drug: Out of specification for assay at the 15-month test interval.

Class IIModerate

FDAAug 4, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nystatin Oral Suspension (PAI Holdings) – Low Potency (2020)

SubPotent Drug: Low out-of-specification results for assay testing.

Class IIModerate

FDAMar 19, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nystatin Oral Suspension (Pharmaceutical Associates) – Subpotent Medication (2020)

Subpotent: Out of specification for assay at the 12-month time point.

Class IIModerate

FDAJan 14, 2020Nationwide• Pharmaceutical Associates Inc

Nystatin Oral Suspension (Pharmaceutical Associates) – Resuspension Issues (2018)

Resuspension problems: Out of specification for appearance and resuspendability.

Class IIILow

FDAMay 29, 2018Nationwide• Pharmaceutical Associates Inc

Cyproheptadine HCl Syrup (Pharmaceutical Associates) – Impurity Issue (2014)

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Class IIModerate

FDAOct 16, 2014Nationwide• Pharmaceutical Associates Inc

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PAI Holdings, LLC. dba Pharmaceutical Associates Inc Recalls

Recall Summary

Guaifenesin Codeine Solution (PAI Holdings) – Superpotent Preservative (2025)

Ethosuximide Oral Solution (PAI Holdings) – CGMP Violation (2021)

Cimetidine Hydrochloride (PAI Holdings) – CGMP Violation (2021)

Nystatin Oral Suspension (PAI) – Potential Senna Carryover (2021)

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Nystatin Oral Suspension (PAI Holdings) – subpotent medication (2020)

Nystatin Oral Suspension (PAI Holdings) – Low Potency (2020)

Nystatin Oral Suspension (Pharmaceutical Associates) – Subpotent Medication (2020)

Nystatin Oral Suspension (Pharmaceutical Associates) – Resuspension Issues (2018)

Cyproheptadine HCl Syrup (Pharmaceutical Associates) – Impurity Issue (2014)