FDA (Drugs) recall action 93159
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
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.
Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.
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.