Why it was recalled
Failed Excipient Specifications: high content of ethylene glycol (EG)
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
Lot numbers, UPCs & expiration codes
Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0126-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 17, 2023
- FDA report date
- Dec 6, 2023
- 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
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm LLC
Original FDA data
Every field from FDA enforcement report D-0126-2024, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 93261
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
- Postal code
- 33771-4809
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0126-2024
- Classification
- Class III
- Recalling firm
- VistaPharm LLC
- 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
- Termination date
- Jul 26, 2024
- Reason for recall
- Failed Excipient Specifications: high content of ethylene glycol (EG)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 17, 2023
- Center classification date
- Nov 28, 2023