Drug product
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
D-0104-2024
Product summary
- Event
- Event 93159
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,136 8 OZ bottles
- Official record key
drug-enforcement:D-0104-2024
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 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.
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.