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PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Complete recall history across all FDA and CPSC categories — 7 total recalls

PAI Holdings, LLC. dba Pharmaceutical Associates Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Date Product Reason Class
Jan 7, 2025 Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16... Superpotent; sodium benzoate preservative Class III
Jul 29, 2021 Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... Lack of CGMP: This recall is being carried out due to potential for carry ove... Class II
Jul 29, 2021 Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY... Lack of CGMP: This recall is being carried out due to potential for carry ove... Class II
Jul 29, 2021 Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Phar... Lack of CGMP: This recall is being carried out due to potential for carry ove... Class II
Sep 9, 2020 Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... Failed Impurities/Degradation Specifications; high out of specification resul... Class III
Aug 4, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... Subpotent drug: Out of specification for assay at the 15-month test interval. Class II
Mar 19, 2020 Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor... SubPotent Drug: Low out-of-specification results for assay testing. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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