FDA Drug recall D-1440-2012
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- FDA Drug
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 by Vistapharm, citing defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the l….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1440-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-30 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Reason
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Identifiers
| code_info | Lot #'s 210900, 214000, 220100, 224800, 228700, 232800 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-11-02 · Vistapharm
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1440-2012%22
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