FDAFDA · Food and drugs·Recall number D-0126-2024
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
Published December 6, 2023 · Recall initiated: October 17, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Excipient Specifications: high content of ethylene glycol (EG)
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- VistaPharm LLC
- Distributor
- Nationwide USA
- Lot
- Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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