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Recall Observatory FDA recall evidence

Drug product

Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.

D-1518-2014

August 06, 2014

Class II

Product summary

Firm
HLI dba Humphreyline Inc
Event
Event 68950
Status
Terminated
Classification
Class II
Quantity
975 bottles
Official record key
drug-enforcement:D-1518-2014

Official wording

Reason: Microbial Contamination of Non-Sterile Product

Code information: Lot #: MB140417; Expiry: 04/2017.

Distribution pattern: Kentucky, Maryland, and Virginia.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination