Drug 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
D-0126-2024
Product summary
- Firm
- VistaPharm LLC
- Event
- Event 93261
- Status
- Terminated
- Classification
- Class III
- 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
- Official record key
drug-enforcement:D-0126-2024
Official wording
Reason: Failed Excipient Specifications: high content of ethylene glycol (EG)
Code information: Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Distribution pattern: Nationwide USA
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol