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CH2O, Inc./ Buckman Laboratories, Inc.

Administrative - Formal · FY2008 · — · Final Order With Penalty · 1400001721

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Penalty
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Cost recovery
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Compliance action

Case

Case Number
10-2008-0159
Type
Administrative - Formal
Lead
EPA
Outcome
Final Order With Penalty
Multimedia
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Self-disclosure
N

Defendants (2)

Summary

CH2O has a distributor agreement with Buckman which allows them to produce and distribute the product MECT-5-CT (EPA Reg. No. 1448-171) under their brand name PACT-5 (EPA Reg. No. 1448-171-43553). CH2O produced, sold, and distributed PACT-5 with a misbranded label. According to CFR40 both the registrant and the distributor can be held liable for this violation. Throughout 2006, CH2O produced PACT-5 with a misbranded/outdated label. This label was missing critical updates to the first aid, directions for use, and the directions for disposal statements. This product had a signal word of “warning” and these are critical updates that need to be current on the product label. This product was placed under a SSURO until corrected. CH2O took immediate action to correct the label and to ensue that all product labels were current and up to date.

Source

Authoritative
EPA ECHO
Machine
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