Highest risk U.S. Food and Drug Administration

Zanilast+ Hand sanitizer recall: Product contains 1-propanol

Recall published 6+ years ago

Product contains 1-propanol.

Zanilast+ Prescription & OTC drugs — recalled prescription & otc drugsZanilast+ Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Zanilast+ Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
August 26, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Zanilast+
Product type
Prescription & OTC drugs
Distribution
California, New Jersey, New York
UPC codes
2000000531151, 2000000531144

Products covered by this recall

Hand sanitizer

What the company announced

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Nanomateriales, SA de CV has not received any reports of adverse events related to this recall.

The product is used as a sanitizer gel, for hand washing to decrease bacteria on the skin and is packaged in 1 liter, 25 kg, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.

  • Presentation: 1 liter · UPC: 2 000000 531151 · NDC: 69912-008-01 · Lable: See below
  • Presentation: 25 kg · NDC: 69912-006-01 · Lable: See below
  • Presentation: 1 gallon · UPC: 2 000000 531144 · NDC: 69912-008-02 · Lable: See below

Nanomateriales, SA de CV is notifying its distributors and customers by e-mail and phone and is arranging for return of all recalled products. Consumers and distributors that have ZANILAST+ GEL which is being recalled should return to place of purchase.

Consumers with questions regarding this recall can contact Nanomateriales SA de CV by phone ( +1 (210)963 5679 ) or e-mail ([email protected]) on working days (Monday through Friday) from 10:00 AM to 5:00 PM, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

CDER’s press statement

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 2000000531151
  • 2000000531144

NDC number

On the carton and again on the bottle or blister label.

  • 69912-008-01
  • 69912-006-01
  • 69912-008-02

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 liter
  • 25 kg
  • 1 gallon

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Zanilast+ — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Nanomateriales, SA de CV — Consumers: Nanomateriales SA de CV, +1-210-963-5679, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Zanilast+ prescription & otc drugs recalled?

Product contains 1-propanol. Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 2000000531151, 2000000531144. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Which states were affected?

The notice lists California, New Jersey, New York.

Related recalls