VistaPharm Recalls Aminocaproic Acid Oral Solution Due to High Ethylene Glycol
VistaPharm LLC is recalling Aminocaproic Acid Oral Solution (0.25 grams/mL) distributed nationwide due to high ethylene glycol content from failed manufacturing specifications. Four lot numbers are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard involves ethylene glycol at elevated levels in the medication formulation, representing a manufacturing quality defect. Class III recalls are typically assigned low-to-moderate severity, and the absence of reported adverse events supports a score of 2 (Moderate).
Plain-English summary
VistaPharm LLC is recalling Aminocaproic Acid Oral Solution, 0.25 grams/mL, a prescription medication packaged in 8 fluid ounce (236.5 mL) bottles. The recall affects four lot numbers: 22ZKY1 (expiration 11/27/23), 22ZMC1 (expiration 12/21/23), 22ZTP1 (expiration 03/29/24), and 23ZAD1 (expiration 07/07/24), which were distributed nationwide across the United States.
The recall was initiated because these batches failed excipient specifications due to high ethylene glycol content. This manufacturing defect affected the product formulation across multiple lots.
The recalled product
- 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
- Manufacturer
- VistaPharm LLC
- Category
- Drug — Oral Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 22ZKY1
- Exp. 11/27/23
- 22ZMC1
- Exp. 12/21/23
- 22ZTP1
- Exp. 03/29/24
- 23ZAD1
- Exp. 07/07/24.
Distribution
Distributed nationwide across the United States.
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