The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0256-2023·Announced 2023-02-08

Easy Clean Isopropyl Alcohol Recalled for Manufacturing Deviations

Frenda Corporation is voluntarily recalling Easy Clean Isopropyl Alcohol 99%, 1-gallon bottles (164 units) due to current Good Manufacturing Practice deviations. The product was distributed in Puerto Rico, lot C030121.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: FDA Class II recall initiated voluntarily by the firm with no reported illnesses or injuries. The hazard is a manufacturing process deviation without a specific identified contamination or product defect, consistent with voluntary precautionary recalls.

Plain-English summary

Frenda Corporation has voluntarily recalled Easy Clean Isopropyl Alcohol 99%, sold in 1-gallon (128 fluid ounce) bottles, due to current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. A total of 164 bottles were affected.

The recall was initiated on December 15, 2022, and the FDA issued a Class II classification on January 30, 2023. A Class II recall indicates that use of or exposure to the product may cause adverse health consequences.

The affected product is identified by lot number C030121 and was distributed in Puerto Rico. The recall status was terminated on September 10, 2024.

The recalled product

Product
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7
Manufacturer
Frenda Corporation
Category
Drug
Hazard
Affected units
164

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 (1)

  • Lot: C030121

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 recalled by Frenda Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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