The Recall Desk
HighFDA (Drugs)·D-0259-2023·Announced 2023-02-08

Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer due to manufacturing practice deviations. The recall affects 124 bottles with lot number C013121 distributed in Puerto Rico.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. Manufacturing practice deviations in a hand sanitizer product represent a theoretical risk to product efficacy, meeting the rubric criterion for a score of 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1-gallon bottles, due to deviations from current good manufacturing practices (cGMP). The affected lot is C013121, and 124 bottles were distributed in Puerto Rico.

The manufacturer voluntarily initiated the recall on December 15, 2022, after identifying these manufacturing practice violations. The recall was terminated on September 10, 2024. No illnesses or injuries have been reported in connection with this product.

The recalled product was distributed only in Puerto Rico under lot number C013121.

The recalled product

Product
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2
Manufacturer
Frenda Corporation
Category
Drug — Hand Sanitizer
Hazard
  • manufacturing-deviation
  • cGMP-violation

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: C013121

Distribution

Distribution scope not specified by the agency.

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