FDA 리콜 사례 참고

 

1. 메탄올 성분 관련 리콜 사례 (손소독제)

 

메탄올 농도가 FDA limit을 초과하는 알코올 소독제 80% 용액은 잠재적으로 메스꺼움, 구토, 두통, 시야 흐림, 신경계 손상 또는 사망을 초래할 수 있습니다. 하지만 부작용에 대한 보고가 되지 않아 전량 리콜된 사례입니다.

 

nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

 

Product Type: Drugs

Reason for Announcement: Due to presence of methanol

Company Name: nanoMaterials Discovery Corporation

Brand Name: nanoMaterials Discovery Corporation

Product Description: Hand Sanitizer

Company Announcement

FOR IMMEDIATE RELEASE – February 14, 2023 – Seattle, Washington, nanoMaterials Discovery Corporation is voluntarily recalling all lots of its Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue” in four fluid ounce spray dispenser packaging to the consumer level.  Certain batches of the company’s Alcohol Antiseptic 80% Alcohol Solution may exceed FDA limits for methanol.

Risk Statement: The affected Alcohol Antiseptic 80% Alcohol Solution with methanol concentrations that exceed FDA limits potentially could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk.  nanoMaterials Discovery Corporation has not received any reports of adverse events related to this recall.

The product is used as a hand sanitizer to help reduce bacteria that potentially can cause disease.  The product is for use when soap and water are not available.  The affected Alcohol Antiseptic 80% Alcohol Solution is packaged in four fluid ounce spray dispenser bottles bearing the code NDC 75288-100-04. The product can be identified by the four fluid ounce spray dispenser bottle packaging and the product labeling pictured below. The affected Alcohol Antiseptic 80% Alcohol Solution was sold nationwide to distributors.  Sales of this product were discontinued in Q4 2021.

nanoMaterials Discovery Corporation is notifying its distributors by mail and is arranging for return or disposal of all recalled products. Consumers/distributors/retailers that have Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue”, which is being recalled, should stop using and return to place of purchase or discard.

Consumers with questions regarding this recall can contact nanoMaterials Discovery Corporation at anesepticrecall@gmail.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

URL: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nanomaterials-discovery-corporation-issues-voluntary-nationwide-recall-its-alcohol-antiseptic-80

 

 

2. 알러지 관련 표기 미비로 인한 리콜 사례 (식품)

 

시중에 판매하는 스낵에 알러지 반응 사례가 보고되지 않았으며, 모든 알러지가 제대로 표기되지 않아 리콜된 사례입니다.

 

Daiso Issues Allergy Alert for Prepackaged Snacks

 

Product Type: Food & Beverages

Reason for Announcement: Undeclared milk, wheat, soy, tree nuts

Company Name: Daiso California, LLC

Brand Name: Various

Product Description: Various Snack Foods

Company Announcement

Daiso California LLC of La Mirada, CA is recalling the below listed snacks due of undeclared allergen ingredients. People who have an allergy or severe sensitivity to milk, soy, wheat, or tree nuts (almonds, cashew, or coconut) run the risk of serious or life-threatening allergic reaction if they consume these products.

These prepackaged snacks were sold in Daiso stores in California, Washington, Nevada, Texas, New York, and New Jersey.

There have been no reported cases of allergic reaction to these products.

The recall was initiated after it was discovered that packaging did not adequately disclose the presence of all allergens. Sale of the products have been suspended, and Daiso California has pulled the products from store shelves.

Consumers who have purchased the below listed snacks may return them to any Daiso store for a full refund. Consumers with questions may contact Daiso at support@daiso-usa.com or call toll free 833-888-1610.

 

SKU	Product Name	Missing Allergen items
4902757413606	MEITO Powdered Apple Tea 4packs	Milk
4901053077376	Potato crackers with small sardines 46g	Milk
4901580002315	Katoseika Chocolate Orange Candy 60g	Soy
4901351055489	KANRO Pure gummy Petit trigonal pyramid grape 17g 3 pieces	Soy
4901050137172	ITOSEIKA Chocolate chip cookies 10pieces	Milk
4902757130909	MEITO Alphabet Chocolate 50g	Tree nut (Coconut)
4970088140546	Onishi Foods Alpha Rice Mushroom Rice 100g	Tree nut (Coconut)
4902757413507	Meito Lemon tea 4P	Milk
4582351890395	Fuyouyakuhin Fruitsaojiru 3g 3packs	Tree nuts (Cashew, Almonds)
4901665004616	Shinsei Additive Free Sesame Sauce 22g	Wheat
4901037117746	IWATSUKASEIKA Ajishirabe Rice Crackers	Wheat, Soy
4901037131919	IWATSUKASEIKA Soybean flavor 72g -21pieces-	Wheat
4902757442804	MEITO An extra Stick Powdered Lemon Tea 5packs	Milk
4901351013137	Kanro Non sugar coffee candy 40g	Tree nut (Coconut)
4902378014053	YAMANAKAFOODS Seasoning - Salted Hijiki Seaweed 20g	Wheat
4902445210500	150YEN HIZATSUKI Soft rice crackers sea lettuce soy sauce flavor	Tree nut (Coconut)
4902757444709	Meito Milk Cocoa 12gX5P (1stick bonus pack)	Tree nut (Coconut)
4901050111400	ITOSEIKA Chocolate chip cookies 10pieces	Milk
4901324017056	Kinjo Seika Potato Yokan 130g	Tree nut (Coconut)
4974120413421	SENNARIDO Green Snack Pistachio 90g	Soy
4967448174211	Igarashiseimen Kitakata Spicy Umakara Ramen	Tree nut (Coconut)
4906436004932	Kurata Menzo Meatfree Tonkotsu Ramen Dry 2P 238.8g	Tree nut (Coconut)
4974120431715	SENNARIDO Green Snack Pistachio -Wasabi Flavor 90g	Soy
4970088140331	Onishi Foods Alpha Rice Matsutake Mushroom Rice 100g	Tree nut (Coconut)

 

URL: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-prepackaged-snacks-0