VistaPharm LLC recalls Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured fo…

Recall date

October 17, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0126-2024

FDA classification

Class III

Brand / firm

VistaPharm LLC

Sold / distributed

Nationwide USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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