The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0365-2021·Announced 2021-05-12

Hand Sanitizer Recalled for Packaging Resembling Drinking Water Bottles

PNHC, LLC. is recalling 139,806 bottles of Heal The World hand sanitizer because the packaging resembles drinking water bottles.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles."

Plain-English summary

PNHC, LLC. is recalling 139,806 bottles of Heal The World, moisturizing original hand sanitizer. The product is a non-sterile, 70% alcohol antiseptic topical solution in 9.6 FL OZ. (285 mL) bottles. The recall is due to the product being packaged in containers that resemble drinking water bottles.

The affected lots are SAA21, SAA22, SAA23, SAA24, SAA25, SAA26, SAA27, SAA28, SAA29, SAA32, SAA44, SAA55, SAA56, and SAA60, all with an expiration date of 5/2022. The product was distributed in Florida and California.

Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.
Manufacturer
PNHC, LLC.
Affected units
139,806

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 (15)

  • Lots: SAA21
  • SAA24
  • SAA27
  • SAA22
  • SAA23
  • SAA29
  • SAA26
  • SAA28
  • SAA25
  • SAA32
  • SAA55
  • SAA56
  • SAA44
  • SAA60
  • expiration 5/2022

Distribution

Distributed in 2 states:

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