Enforcement Report - Week of November 21, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | D-056-2013 |
| Classification | Class III |
| Code Info | Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 63428 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | ITW Dymon |
| City | Olathe |
| State | KS | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-28 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide |
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