Recalls / Class II
Class IID-0285-2019
Product
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
- Affected lot / code info
- Lot #: 13417 Exp. 05/2020
Why it was recalled
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1602 bags
- Distribution pattern
- WA only
Timeline
- Recall initiated
- 2018-11-20
- FDA classified
- 2018-11-28
- Posted by FDA
- 2018-12-05
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0285-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.