D-1318-2019 Class II Terminated
FDA drug recall D-1318-2019 was initiated by Inopak Ltd on April 22, 2019 and is designated Class II. Reason for recall: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. The recall status is terminated (terminated August 28, 2024). Affected quantity: 17,850 pounds per batch.
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2019
- Initiation Date
- April 22, 2019
- Termination Date
- August 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,850 pounds per batch
Product Description
Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ.
Reason for Recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Distribution Pattern
Nationwide in the USA
Code Information
Batch #: 6660, 6664, 6676, 6682, 6685, 6698 ,6701, 6725, 6732, 6742, 6744, 6746, 6756, 6762, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6820, 6829, 6839, 6868, 6872, 6875, 6891, 6892, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6952, 6958, 6963, 6970, 6978, 6982, 6987, 6993, 6997, 7004, 7006, 7024, 7038, 7049, 7054, 7056, 7058, 7078, 7087, 7098, 7104, 7108, 7111, 7129, 7132, 7134, 7138, 7145, 7152, 7157, 7160, 7164, 7170, 7177, 7184, 7190, 7192, 7203, 7207, 7220, 7224, 7231, 7235, 7237, 7243, 7247, 7252, 7258, 7260, 7269, 7281, 7285, 7291, 7296, 7301, 7306, 7311, 7312, 7319, 7322, 7326, 7335, 7338, 7340, 7347, 7351, 7353, 7368, 7377, 7384, 7387, 7394 and 7399