← FDA ENFORCEMENT
D-0105-2024Class II

Omega & Delta Co., Inc.

Recalling firm
Omega & Delta Co., Inc.
Product type
Drug
Status
Ongoing
Report date
2023-11-22
Distribution
Distributed in Puerto Rico only.
Firm state
PR
Product quantity
4,848 7.5 oz bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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.

Product description

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

Code / lot info

Lot #s 006511

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.