Recall Enforment Report D-0017-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Beiersdorf Inc, originally initiated on 09-30-2021 for the product Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0017-202209-30-202110-27-2021Class II14,748 cansCoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7cGMP DeviationsOngoing
D-0013-202209-30-202110-27-2021Class I142,236 cansCoppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1Chemical contamination; presence of benzeneOngoing
D-0015-202209-30-202110-27-2021Class II36,660 cansCoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0cGMP DeviationsOngoing
D-0014-202209-30-202110-27-2021Class I143,376 cansCoppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9Chemical contamination; presence of benzeneOngoing
D-0010-202209-30-202110-27-2021Class I38,328 cansCoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0Chemical contamination; presence of benzeneOngoing
D-0012-202209-30-202110-27-2021Class I124,668 cansCoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7Chemical contamination; presence of benzeneOngoing
D-0011-202209-30-202110-27-2021Class I167,808 cansCoppertone 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 4Chemical contamination; presence of benzeneOngoing
D-0016-202209-30-202110-27-2021Class II70,320 cansCoppertone 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 4cGMP DeviationsOngoing