The Recall Desk
SevereFDA (Drugs)·D-0864-2018·Announced 2018-06-20

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

Related recalls

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Same hazard · microbial contamination

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