FDA recall D-0126-2024

Product

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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2023-10-17

Report date

2023-12-06

Termination date

2024-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2024