FDA Recall D-0104-2024

Omega & Delta Co., Inc. · Carolina, PR

Class II Ongoing 937 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #s 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.

Quantity: 23,136 8 OZ bottles

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.

Recall record

Recall number: D-0104-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed in Puerto Rico only.
Recall initiated: 2023-10-20
Classified by FDA Center: 2023-11-14
FDA published: 2023-11-22
Recalling firm: Omega & Delta Co., Inc.
Firm location: Carolina, PR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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