Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text identifies this as an FDA Class II recall for cGMP deviations. The recall is voluntary, precautionary in nature, and involves manufacturing process defects rather than reported illness or injury. No illnesses or injuries are reported in the source material.
Plain-English summary
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray (Zinc Oxide 24.08%, 5 OZ/142 g can) with Lot# TN00857 and expiration date 04/30/2023. The product was distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified in the manufacturing process. Beiersdorf Inc. began this voluntary recall on September 30, 2021, and notified the FDA by letter. The FDA classified this as a Class II recall on October 15, 2021.
Consumers who have purchased the affected product should stop using it. The recall was terminated on April 13, 2023. For more information, consumers should contact Beiersdorf Inc. or visit the FDA's drug recall database.
The recalled product
- Product
- Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
- Manufacturer
- Beiersdorf Inc
- Category
- Drug — Sunscreen
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (2)
- Lot# TN00857
- exp. date 04/30/2023
Distribution
Distributed nationwide across the United States.
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