D-0126-2024 Class III Terminated
FDA drug recall D-0126-2024 was initiated by VistaPharm LLC on Oct 17, 2023 and is designated Class III. Reason for recall: Failed Excipient Specifications: high content of ethylene glycol (EG) The recall status is terminated (terminated Jul 26, 2024). Affected 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…
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 6, 2023
- Initiation Date
- Oct 17, 2023
- Termination Date
- Jul 26, 2024
- 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
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
Reason for Recall
Failed Excipient Specifications: high content of ethylene glycol (EG)
Distribution Pattern
Nationwide USA
Code Information
Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0126-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026