Drug product
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.
D-056-2013
Product summary
- Firm
- ITW Dymon
- Event
- Event 63428
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 216 cases; b) 75 cases; c) 29 cases
- Official record key
drug-enforcement:D-056-2013
Official wording
Reason: CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Code information: Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations