Drug recall
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles…
FDA recall event 93261 · Class III · VistaPharm LLC
Key facts
| Event ID | 93261 |
|---|---|
| Recall numbers | D-0126-2024 |
| Recalling firm | VistaPharm LLC |
| Product type | Drugs |
| Products | Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Excipient Specifications: high content of ethylene glycol (EG) |
| Initiation date | Oct 17, 2023 |
| Report date | Dec 6, 2023 |
| Termination date | Jul 26, 2024 |
| City | Largo |
| State | FL |
| Country | United States |
| FEI number | 1036352 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: