Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for
Summary
The FDA issued a Class III for Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. ( by VistaPharm LLC. Reason: Failed Excipient Specifications: high content of ethylene glycol (EG).
Details
Source
Drug Recall
External ID
D-0126-2024
Action Date
2023-12-06
Status
Terminated
Category
drug
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/Code Info: Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Quantity 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
Reason for Recall
Failed Excipient Specifications: high content of ethylene glycol (EG)
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-17
Company
Largo, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VistaPharm LLC has 11 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VistaPharm LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VistaPharm LLC have FDA actions?
VistaPharm LLC has 11 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0126-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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