VistaPharm LLC: Drug Recall

Recall #D-0126-2024 · 10/17/2023

Class III: Low Risk

Recall Details

Recall Number: D-0126-2024
Classification: Class III
Product Type: Drug
Recalling Firm: VistaPharm LLC
Status: Terminated
Date Initiated: 10/17/2023
Location: Largo, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide USA

Other Recalls by VistaPharm LLC

Class III: Low Risk 10/26/2023

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I: Dangerous 10/18/2023

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class II: Risk 08/30/2023

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

View all recalls by VistaPharm LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.