FDA-Drug2023-12-06Class III
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
VistaPharm LLC
Hazard
Failed Excipient Specifications: high content of ethylene glycol (EG)
Sold states
Nationwide USA
Affected count
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
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2024Don't want to check this manually?
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