Medical Device
Manufacturing
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Z-1407-05

ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal...

ITW Dymon / initiated 2005-02-15 / Terminated

ITW Dymon began a recall of ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel... on . The reason FDA records is "Failed EPA required efficacy testing; may not perform as intended". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1407-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ITW Dymon
Product
ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.
Reason for recall
Failed EPA required efficacy testing; may not perform as intended.
FDA root cause
Other
Action
Telephone calls were initiated to the direct accounts on 2/15/05 and by letter initiated 2/21/05 requesting return of the product and subrecall by the direct account, unless the direct account preferred the recalling firm to conduct the subaccount recall. The recall was later expanded and recall letters dated 4/29/05 were issued requesting the same information as the initial letter.
Quantity in commerce
260/12-can cases
Distribution
Distribution was nationwide to wholesalers and own-label distributors.
Product codes and lots
Initially recalled lot number: Private label - A66241;  Expanded recalled lot numbers: Private label - A23141 and A28141