Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethy...
FDA Recall #D-056-2013 — Class III — September 28, 2012
Product Description
Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9.
Reason for Recall
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Recalling Firm
ITW Dymon — Olathe, KS
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
a) 216 cases; b) 75 cases; c) 29 cases
Distribution
Nationwide
Code Information
Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated