DOP Instant Hand Sanitizer Recalled for Potency Compliance Failures
Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer because they do not meet established potency standards. Some batches are sub-potent or super-potent, potentially affecting antimicrobial effectiveness or causing irritation.
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: Risk-of-harm product with material potency non-compliance. Sub-potent batches may provide inadequate antimicrobial protection, and super-potent batches could cause skin irritation. No illnesses or injuries have been reported, meeting the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 4 FL OZ (118 ml) bottles that were distributed in Puerto Rico only. During a quality impact assessment, it was identified that several distributed lots did not comply with the finished-product acceptance criteria established for this hand sanitizer.
The affected lots contain potency levels outside acceptable specifications. Some batches are sub-potent, containing less than the specified 65% ethyl alcohol concentration, which may not provide adequate antimicrobial protection. Other batches are super-potent, exceeding the specified concentration, which could potentially cause skin irritation with use.
This recall affects approximately 48,145 four-ounce bottles distributed in Puerto Rico. The affected lot numbers are 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, and 0252099. Consumers who have purchased products from these lots should stop using the product and discard it. No illnesses or injuries related to this product have been reported to date.
The recalled product
- 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
- Manufacturer
- Omega & Delta Co., Inc.
- Category
- Drug — Hand Sanitizer
- Hazard
- sub-potency
- super-potency
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 (11)
- Lot #s 1327034
- 1328034
- 1277029
- 1278029
- 1202015
- 1203015
- 0246097
- 0247097
- 0247099
- 0248099
- 0252099
Distribution
Distribution scope not specified by the agency.
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