CLASS II Drug recall · Reported 5 Dec 2018 · FDA Enforcement Report
Germ Bloc Health Hand Sanitizer Foam recalled by AVKARE
Avkare is recalling Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) refill, AvKARE, Inc, distributed in Washington. The recall was initiated on 20 Nov 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0285-2019
- FDA event ID
- 81603
- Recalling firm
- Avkare, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2018
- FDA classified
- 28 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Hand Sanitizer
Timeline
| 20 Nov 2018 | Recall initiated by company | |
| 28 Nov 2018 | Classified by FDA | +8 days |
| 5 Dec 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
Where it was distributed
WA only
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Which lots are affected?
Lot #: 13417 Exp. 05/2020
Where was it sold?
WA only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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