Drug product
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.
D-1318-2019
Product summary
- Firm
- Inopak Ltd
- Event
- Event 82645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,850 pounds per batch
- Official record key
drug-enforcement:D-1318-2019
Official wording
Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations