Drug Enforcement D-056-2013

CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.

Status

Terminated

Classification

Class III

Report Date

November 21, 2012

Termination Date

March 25, 2014

Product Information

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.
Product quantity
a) 216 cases; b) 75 cases; c) 29 cases
Reason for recall
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Nationwide

Location & Firm

Recalling firm
ITW Dymon
Address
805 E Old 56 Hwy

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-056-2013
Event ID
63428
Recall initiation date
September 28, 2012
Center classification date
November 15, 2012
Code info
Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15
More code info