Drug product
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
D-0920-2018
Product summary
- Event
- Event 80473
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,128 tubes
- Official record key
drug-enforcement:D-0920-2018
Official wording
Reason: Incorrect Product Formulation: wrong sunscreen product in the package.
Code information: Lot Codes: a) 7363B, 7363I, 8002C, 8002I, 8054J, 8055B, 8174A; and b) 7353
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Incorrect Product Formulation: wrong sunscreen product in the package.