Drugplain

Eye Wash 991 mg/mL

WATER · LIQUID · Jiangxi Zhenmei Biological Technology Co.,Ltd

10 Recalls on RecordCurrently in Shortage
Plain English

Eye Wash is a liquid containing water at 991 mg/mL, taken topical. Manufactured by Jiangxi Zhenmei Biological Technology Co.,Ltd.

Key Facts

Brand Name
Eye Wash
Generic Name
WATER
NDC Code (Product)
82001-001
Manufacturer
Jiangxi Zhenmei Biological Technology Co.,Ltd
Strength
991 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
07/07/2021

Recall History

10 Recalls on Record
Class II09/02/2016

United Exchange Corporation

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II09/02/2016

United Exchange Corporation

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II02/16/2017

Sato Pharmaceutical Inc.

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

TerminatedVoluntary: Firm initiated
Class I09/02/2016

United Exchange Corporation

Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated

Frequently Asked Questions

What is Eye Wash used for?

Eye Wash contains WATER. It is a liquid taken topical. Consult your doctor for specific uses.

Is Eye Wash a controlled substance?

Eye Wash is not classified as a controlled substance by the DEA.

What is the generic name for Eye Wash?

The generic name for Eye Wash is WATER. There are 11 other brand versions of WATER.

What is the NDC code for Eye Wash 991 mg/mL?

The NDC (National Drug Code) for Eye Wash 991 mg/mL is 82001-001, listed by Jiangxi Zhenmei Biological Technology Co.,Ltd.