Status
Terminated
Drug Enforcement D-0126-2024
Failed Excipient Specifications: high content of ethylene glycol (EG)
Classification
Class III
Report Date
December 6, 2023
Termination Date
July 26, 2024
Product Information
- 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
- 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
- Reason for recall
- Failed Excipient Specifications: high content of ethylene glycol (EG)
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide USA
Location & Firm
- Recalling firm
- VistaPharm LLC
- Address
-
7265 Ulmerton Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0126-2024
- Event ID
- 93261
- Recall initiation date
- October 17, 2023
- Center classification date
- November 28, 2023
- Code info
- Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
- More code info
- —