The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1532-2019·Announced 2019-08-07

NingBo Huize Recalls SPF 30 Sunscreen Lotion Due to Missing Stability Testing

NingBo Huize Commodity Co., Ltd. is recalling SPF 30 Sunscreen Lotion because stability testing was not conducted on the manufactured product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

NingBo Huize Commodity Co., Ltd. is recalling 10,000 units of SPF 30 Sunscreen Lotion. The product contains Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%, and Titanium Dioxide 2.5% and is distributed by EVANS. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products.

The affected products were manufactured in China and distributed to seven consignees located in China. The recall covers two specific lots: Lot # 20180709 (Expiration 07/08/2020) and Lot # 20180710 (Expiration 07/09/2020). The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who possess these specific lots of the product should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China
Manufacturer
NingBo Huize Commodity Co.,Ltd.
Category
Drug — OTC Sunscreen
Hazard

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 (4)

  • Lot #: 20180709
  • Exp 07/08/2020
  • 20180710
  • Exp 07/09/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 36 recalled by NingBo Huize Commodity Co.,Ltd. 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 36 products in this recall →

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