FDA Drug recall 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 Associ…
- FDA Drug
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 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) bottle, Rx ONLY, pai Pharmaceutical Associ… by Pai Holdings, citing subPotent Drug: Low out-of-specification results for assay testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1060-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-19 |
| Published | 2020-04-01 |
| 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) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Reason
SubPotent Drug: Low out-of-specification results for assay testing.
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: BE85, Exp. 11/2020 |
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-1060-2020%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.