FDA Recall D-0166-2023

Southwest Iowa Renewable Energy LLC · Council Bluffs, IA

Class II Ongoing 1316 days on record

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

Product

SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522.

Lot / code: Lots: 0001, 0005, 0007

Quantity: a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles

Reason for recall

CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.

Recall record

Recall number: D-0166-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: IA, NE
Recall initiated: 2022-10-06
Classified by FDA Center: 2023-01-19
FDA published: 2023-01-25
Recalling firm: Southwest Iowa Renewable Energy LLC
Firm location: Council Bluffs, IA

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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