Why it was recalled
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Product description
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
Lot numbers, UPCs & expiration codes
All lots within expiry
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-0004-2018
- 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-0004-2018, 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
- All lots within expiry
- Postal code
- 07456-1430
- Report date
- Oct 11, 2017
- Product type
- Drugs
- Recall number
- D-0004-2018
- 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
- Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
- Distribution pattern
- nationwide
- Recall initiation date
- Aug 23, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2017