Why it was recalled
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Product description
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
Lot numbers, UPCs & expiration codes
Batch Numbers 6718, 6730, 6744, 6754, 6760, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6938, 6944, Style Batch Numbers 6725, 6732, 6735, 6742, 6756, 6762, 6766, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6829, 6839, 6868, 6872, 6875, 6891, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6820
Where it was sold
nationwide
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-0002-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2017
- FDA report date
- Oct 11, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inopak Ltd
Original FDA data
Every field from FDA enforcement report D-0002-2018, exactly as published.
Show all FDA fields
- City
- Ringwood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78098
- Address
- 24 Executive Pkwy
- Code information
- Batch Numbers 6718, 6730, 6744, 6754, 6760, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6938, 6944, Style Batch Numbers 6725, 6732, 6735, 6742, 6756, 6762, 6766, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6829, 6839, 6868, 6872, 6875, 6891, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6820
- Postal code
- 07456-1430
- Report date
- Oct 11, 2017
- Product type
- Drugs
- Recall number
- D-0002-2018
- Classification
- Class II
- Recalling firm
- Inopak Ltd
- Termination date
- Apr 20, 2020
- Reason for recall
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
- Distribution pattern
- nationwide
- Recall initiation date
- Aug 23, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2017