FDA Recall Nystatin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Nystatin with NDC 0121-4810 was initiated on 08-04-2020 as a Class II recall due to subpotent drug: out of specification for assay at the 15-month test interval. The latest recall number for this product is D-1494-2020 and the recall is currently terminated as of 09-22-2021 .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-1494-2020 | 08-04-2020 | 08-19-2020 | Class II | 7416 bottles | 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 |
D-1060-2020 | 03-19-2020 | 04-01-2020 | Class II | 7416 bottles | 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. | Terminated |
D-0824-2020 | 01-14-2020 | 02-05-2020 | Class II | 6288 16 oz bottles | Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16 | Terminated |
D-0865-2018 | 05-29-2018 | 06-13-2018 | Class III | 275400 cups | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.