Greenville, SC, United States
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls
5 recalls recorded since 2018, most recently on 7 January 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 7 January 2025
- Terminated
- 25 July 2026
- Reason
- Superpotent; sodium benzoate preservative
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0222-2025
- Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
Terminated Class II Drugs
- Recall started
- 29 July 2021
- Terminated
- 2 December 2022
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0723-2021, D-0722-2021, D-0721-2021
- Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
- Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
- Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates,
Terminated Class III Drugs
- Recall started
- 9 September 2020
- Terminated
- 22 February 2022
- Reason
- Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0015-2021
- Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
Terminated Class II Drugs
- Recall started
- 4 August 2020
- Terminated
- 22 September 2021
- Reason
- Subpotent drug: Out of specification for assay at the 15-month test interval.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1494-2020
- Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Terminated Class II Drugs
- Recall started
- 19 March 2020
- Terminated
- 22 September 2021
- Reason
- SubPotent Drug: Low out-of-specification results for assay testing.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1060-2020
- Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.