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
Reported: December 6, 2023 Initiated: October 17, 2023 #D-0126-2024
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)
Details
- Recalling Firm
- VistaPharm LLC
- Units Affected
- 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
- Nationwide USA
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by VistaPharm LLC. Units affected: 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.
Why was this product recalled? ▼
Failed Excipient Specifications: high content of ethylene glycol (EG)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 6, 2023. Severity: Low. Recall number: D-0126-2024.
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