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

Recall Number: D-0126-2024

Firm: VistaPharm LLC

Classification: Class III

Status: Terminated

Report Date: 20231206

Initiation Date: 20231017

Termination Date: 20240726

Failed Excipient Specifications: high content of ethylene glycol (EG)

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