Key Takeaway

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 by PAI Holdings, LLC. dba Pharmaceutical Associates Inc was recalled on August 4, 2020. The hazard: Subpotent drug: Out of specification for assay at the 15-month test interval.

FDA Drug Class II Terminated

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

Recalled: August 4, 2020 ~7416 bottles units affected D-1494-2020

Description

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Greenville, SC, United States

View all 7 recalls by PAI Holdings, LLC. dba Pharmaceutical Associates Inc →

Distribution

Nationwide USA

Related Recalls

FDA Drug Class III

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

January 7, 2025
FDA Drug Class II

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

July 29, 2021
FDA Drug Class II

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

July 29, 2021
FDA Drug Class II

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: Pharmac

July 29, 2021
FDA Drug Class III

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

September 9, 2020
FDA Drug Class II

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.

March 19, 2020

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.