Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Product description
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456.
Lot numbers, UPCs & expiration codes
Batch #: 6657, 6666, 6671, 6679, 6687, 6695, 6702, 6718, 6730, 6744, 6754, 6760, 6772, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6856, 6862, 6877, 6890, 6896, 6902, 6910, 6919, 6938, 6944, 6953, 6971, 6985, 6990, 6998, 7005, 7012, 7018, 7028, 7033, 7039, 7043, 7053, 7060, 7068, 7080, 7092, 7101, 7110, 7116, 7126, 7143, 7153, 7161, 7167, 7175, 7188, 7204, 7208, 7213, 7221, 7232, 7242, 7248, 7267, 7275, 7284, 7287, 7295, 7308, 7314, 7324, 7329, 7336, 7348, 7357, 7363, 7372, 7382, 7389, 7397, 7403, and 7411
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1310-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2019
- FDA report date
- Jun 5, 2019
- Quantity
- 17,850 pounds per batch
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inopak Ltd
Original FDA data
Every field from FDA enforcement report D-1310-2019, exactly as published.
Show all FDA fields
- City
- Ringwood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82645
- Address
- 24 Executive Pkwy
- Code information
- Batch #: 6657, 6666, 6671, 6679, 6687, 6695, 6702, 6718, 6730, 6744, 6754, 6760, 6772, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6856, 6862, 6877, 6890, 6896, 6902, 6910, 6919, 6938, 6944, 6953, 6971, 6985, 6990, 6998, 7005, 7012, 7018, 7028, 7033, 7039, 7043, 7053, 7060, 7068, 7080, 7092, 7101, 7110, 7116, 7126, 7143, 7153, 7161, 7167, 7175, 7188, 7204, 7208, 7213, 7221, 7232, 7242, 7248, 7267, 7275, 7284, 7287, 7295, 7308, 7314, 7324, 7329, 7336, 7348, 7357, 7363, 7372, 7382, 7389, 7397, 7403, and 7411
- Postal code
- 07456-1430
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1310-2019
- Classification
- Class II
- Recalling firm
- Inopak Ltd
- Product quantity
- 17,850 pounds per batch
- Termination date
- Aug 28, 2024
- Reason for recall
- CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- May 29, 2019