FDA Drug recall D-0865-2018
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, I…
- FDA Drug
- Class III
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class III recall of Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, I… by Pharmaceutical Associates, citing resuspension problems: Out of specification for appearance and resuspendability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0865-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-05-29 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmaceutical Associates |
| Distribution | US |
Product
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
Reason
Resuspension problems: Out of specification for appearance and resuspendability.
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: B5B8 Exp. 07/2019 |
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-0865-2018%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.