FDAClass IIJune 5, 2019

Sani-Guard-SF Waterless Foam Hand Sanitizer recall: CGMP Deviations

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD

Why was Sani-Guard-SF Waterless Foam Hand Sanitizer recalled?

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch #: 6668, 6721

Product
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
Recalling firm
Inopak Ltd
Quantity
17,850 pounds per batch
Distribution
Nationwide in the USA
Recall date
June 5, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls