DOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico
Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for hand sanitizer with non-compliant potency. No illnesses or injuries reported, but potency defects in a sanitizing product constitute a risk-of-harm product, justifying High severity.
Plain-English summary
Omega & Delta Co., Inc. is recalling DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8 FL OZ (237 mL) bottles. Approximately 23,136 bottles are affected by this recall.
An impact assessment identified that certain lot numbers did not comply with established finished product acceptance criteria for potency. The affected lot numbers are: 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, and 0245096.
The recalled product was distributed in Puerto Rico only. This is an FDA Class II recall.
The recalled product
- 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
- Manufacturer
- Omega & Delta Co., Inc.
- Category
- Drug — Hand Sanitizer
- Hazard
- potency-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #s 1113005
- 1116005
- 0237088
- 0232084
- 012764
- 012864
- 0244096
- 0245096.
Distribution
Distribution scope not specified by the agency.
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