Inopak Recalls Antibacterial Foaming Hand Wash Due to Microbial Contamination
Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash because FDA analysis found out-of-specification microbial counts.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches. The recall involves 1,345 cases of the product distributed nationwide. The specific lot codes affected are 7302 01 039, 7302 03 039, 7302 01 040, and 7302 01 043.
The recall was initiated because FDA analysis returned out-of-specification results for total aerobic microbial counts, indicating microbial contamination of the non-sterile product. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact Inopak Ltd for further instructions or a refund.
The recalled product
- Product
- Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
- Manufacturer
- Inopak Ltd
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 1,345
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 7302 01 039
- 7302 03 039
- 7302 01 040 and 7302 01 043
Distribution
Distributed nationwide across the United States.
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