Why it was recalled
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Product description
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Lot numbers, UPCs & expiration codes
7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043
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-0864-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 1345 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inopak Ltd
Original FDA data
Every field from FDA enforcement report D-0864-2018, exactly as published.
Show all FDA fields
- City
- Ringwood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80196
- Address
- 24 Executive Pkwy
- Code information
- 7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043
- Postal code
- 07456-1430
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0864-2018
- Classification
- Class II
- Recalling firm
- Inopak Ltd
- Product quantity
- 1345 cases
- Termination date
- Oct 23, 2020
- Reason for recall
- Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
- Distribution pattern
- Nationwide
- Recall initiation date
- May 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 13, 2018