Drug 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
D-0285-2019
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 81603
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1602 bags
- Official record key
drug-enforcement:D-0285-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Code information: Lot #: 13417 Exp. 05/2020
Distribution pattern: WA only
Derived failure modes
-
Microbial contamination
Microbial Contamination