Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations
Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with voluntary manufacturer-initiated action for CGMP deviations. No illnesses or injuries reported; this is a manufacturing process issue rather than a direct health hazard.
Plain-English summary
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%) is being recalled by Parker Laboratories, Inc. The recall affects two package sizes: 2 fl oz pump bottles (NDC 30775-040-02) with Lot #G0323002 (expiration 3/1/2025) and 18 fl oz pump bottles (NDC 30775-040-18) with Lot #G1122001 (expiration 11/15/2024).
The reason for the recall is Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. The recall is voluntary and was initiated by the manufacturer. This recall was terminated on June 3, 2024.
The affected products were distributed nationwide in the United States as well as in Singapore, Korea, and Hong Kong. Consumers should stop using the product and dispose of it safely. No illnesses or injuries have been reported.
The recalled product
- 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
- Manufacturer
- Parker Laboratories, Inc.
- Category
- Drug — Hand Sanitizer
- Hazard
- cgmp-deviation
- manufacturing-quality
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) G0323002
- Exp. Date 3/1/2025 Lot #: b) G1122001
- Exp. Date 11/15/2024
Distribution
Distributed nationwide across the United States.
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