Recalls / Class II
Class IID-1089-2023
Product
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
- Affected lot / code info
- Lot #: a) G0323002, Exp. Date 3/1/2025 Lot #: b) G1122001, Exp. Date 11/15/2024
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Parker Laboratories, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 286 Eldridge Rd, N/A, Fairfield, New Jersey 07004-2509
Distribution
- Quantity
- 9
- Distribution pattern
- Nationwide within the United States, Singapore, Korea and Hong Kong
Timeline
- Recall initiated
- 2023-08-02
- FDA classified
- 2023-08-18
- Posted by FDA
- 2023-08-30
- Terminated
- 2024-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1089-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.