October 2022 FDA Recall Drug by Southwest Iowa Renewable Energy Llc
D-0166-2023 - CGMP Deviations and Superpotent Drug

This Class II drug recall was voluntarily initiated by Southwest Iowa Renewable Energy Llc on October 6, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations and superpotent drug. The product was distributed in IA, NE and the recall is currently ongoing.

Recall Number: D-0166-2023

Reason for Recall
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Initiated
10-06-2022
Reported
01-25-2023
Quantity
a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90953
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Southwest Iowa Renewable Energy LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IA, NE
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lots: 0001, 0005, 0007