FDA Drug recall D-0723-2021
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc by Pai Holdings, citing lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0723-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-29 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pai Holdings |
| Distribution | US |
Product
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Identifiers
| ndc | 0121-0670-16 |
|---|---|
| code_info | Lot: C9BC Exp. 31OCT2022 |
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-0723-2021%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.