Why it was recalled
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Product description
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
Lot numbers, UPCs & expiration codes
Lot #: 13417 Exp. 05/2020
Where it was sold
WA only
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-0285-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2018
- FDA report date
- Dec 5, 2018
- Quantity
- 1602 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0285-2019, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 81603
- Address
- 615 N 1st St
- Code information
- Lot #: 13417 Exp. 05/2020
- Postal code
- 38478-2403
- Report date
- Dec 5, 2018
- Product type
- Drugs
- Recall number
- D-0285-2019
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 1602 bags
- Termination date
- May 7, 2020
- Reason for recall
- Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
- Distribution pattern
- WA only
- Recall initiation date
- Nov 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 28, 2018