Drugplain

Keystone 5 mg/mL

Benzalkonium Chloride · SOLUTION · Ecolab Inc.

4 Recalls on Record
Plain English

Keystone is a solution containing benzalkonium chloride at 5 mg/mL, taken topical. Manufactured by Ecolab Inc..

Key Facts

Brand Name
Keystone
Generic Name
Benzalkonium Chloride
NDC Code (Product)
47593-561
Manufacturer
Ecolab Inc.
Strength
5 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
12/21/2016

Recall History

4 Recalls on Record
Class II11/14/2024

Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

TerminatedVoluntary: Firm initiated
Class II04/04/2016

Keystone Laboratories Inc

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

TerminatedVoluntary: Firm initiated
Class II02/08/2016

Keystone Laboratories Inc

Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.

TerminatedVoluntary: Firm initiated
Class II10/17/2024

Keystone Industries

Subpotent Drug

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is Keystone used for?

Keystone contains Benzalkonium Chloride. It is a solution taken topical. Consult your doctor for specific uses.

Is Keystone a controlled substance?

Keystone is not classified as a controlled substance by the DEA.

What is the generic name for Keystone?

The generic name for Keystone is Benzalkonium Chloride. There are 12 other brand versions of Benzalkonium Chloride.

What is the NDC code for Keystone 5 mg/mL?

The NDC (National Drug Code) for Keystone 5 mg/mL is 47593-561, listed by Ecolab Inc..