Recalls / Class III
Class IIID-0126-2024
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
- Affected lot / code info
- Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Why it was recalled
Failed Excipient Specifications: high content of ethylene glycol (EG)
Recalling firm
- Firm
- VistaPharm LLC
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- 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
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-10-17
- FDA classified
- 2023-11-28
- Posted by FDA
- 2023-12-06
- Terminated
- 2024-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0126-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.