FDA Drug recall 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
- FDA Drug
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc by Pai Holdings, citing subpotent drug: Out of specification for assay at the 15-month test interval.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1494-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-04 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pai Holdings |
| Distribution | US |
Product
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
Reason
Subpotent drug: Out of specification for assay at the 15-month test interval.
Identifiers
| ndc | 0121-0810-02 |
|---|---|
| ndc | 0121-0810-16 |
| ndc | 0121-4810-05 |
| ndc | 0121-4810-40 |
| ndc | 0121-4810-00 |
| ndc | 0121-4810-50 |
| code_info | Lot: B973, Exp 11/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1494-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.