D-0285-2019 Class II Terminated
FDA drug recall D-0285-2019 was initiated by AVKARE Inc. on Nov 20, 2018 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product The recall status is terminated (terminated May 7, 2020). Affected quantity: 1602 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 5, 2018
- Initiation Date
- Nov 20, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1602 bags
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Distribution Pattern
WA only
Code Information
Lot #: 13417 Exp. 05/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0285-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026