Drug product
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
D-0103-2024
Product summary
- Event
- Event 93159
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48,145 4 oz bottles
- Official record key
drug-enforcement:D-0103-2024
Official wording
Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Code information: Lot #s 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, 0252099
Distribution pattern: Distributed in Puerto Rico only.
Derived failure modes
-
Unknown
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.