Drug product
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
D-1078-2018
Product summary
- Event
- Event 80648
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,098 tubes
- Official record key
drug-enforcement:D-1078-2018
Official wording
Reason: Microbial Contamination of a Non-Sterile Product
Code information: Lot code 8041
Distribution pattern: Product was distributed to one distributor in California who may have distributed the product further within the US.
Derived failure modes
-
Microbial contamination
Microbial Contamination