Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Product description
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
Lot numbers, UPCs & expiration codes
Batch #: 6802, 6803, 6909, 6655
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-1315-2019
- 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-1315-2019, 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 #: 6802, 6803, 6909, 6655
- Postal code
- 07456-1430
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1315-2019
- 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 Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- May 29, 2019