FDA Drug recall D-0854-2021
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Pa…
- FDA Drug
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Pa… by American Health Packaging, citing CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0854-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-15 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Identifiers
| code_info | Lot 1000082; Exp 06/30/2022 |
|---|
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-0854-2021%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.