VistaPharm LLC recalls Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for
Recalled December 6, 2023 · FDA recall D-0126-2024 · VistaPharm
Hazard
Failed Excipient Specifications: high content of ethylene glycol (EG) · FDA Class III
Units
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
Sold at
Nationwide USA
Description
Failed Excipient Specifications: high content of ethylene glycol (EG)
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
Manufacturer(s)
VistaPharm LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →