Drug recall
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only…
FDA recall event 86170 · Class II · PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Key facts
| Event ID | 86170 |
|---|---|
| Recall numbers | D-1494-2020 |
| Recalling firm | PAI Holdings, LLC. dba Pharmaceutical Associates Inc |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent drug: Out of specification for assay at the 15-month test interval. |
| Initiation date | Aug 4, 2020 |
| Report date | Aug 19, 2020 |
| Termination date | Sep 22, 2021 |
| City | Greenville |
| State | SC |
| Country | United States |
| FEI number | 1017687 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: