Drugplain

GloStrips 1 mg/1

Fluorescein Sodium · STRIP · Nomax Inc.

4 Recalls on Record
Plain English

GloStrips is a strip containing fluorescein sodium at 1 mg/1, taken ophthalmic. Manufactured by Nomax Inc..

Key Facts

Brand Name
GloStrips
Generic Name
Fluorescein Sodium
NDC Code (Product)
51801-009
Manufacturer
Nomax Inc.
Strength
1 mg/1
Dosage Form
STRIP
Route
OPHTHALMIC
Marketing Status
Marketing Start
07/30/2013

Recall History

4 Recalls on Record
Class II04/19/2024

Nomax Inc

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

OngoingVoluntary: Firm initiated
Class III03/24/2015

Nomax Inc

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.

TerminatedVoluntary: Firm initiated
Class III03/24/2015

Nomax Inc

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

TerminatedVoluntary: Firm initiated
Class II04/19/2024

Nomax Inc

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pruritus48 reports
rash32 reports
anaphylactic shock28 reports
nausea27 reports
dizziness23 reports
vomiting21 reports
chest discomfort18 reports
urticaria18 reports
dyspnoea16 reports
hyperhidrosis16 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Rose Bengal ophthalmic strips are used as a diagnostic agent in routine ocular examinations or when superficial conjunctiva or corneal tissue change is suspected. Rose Bengal ophthalmic strips can also serve as an effective aid in the diagnosis of keratoconjunctivitis sicca, keratitis, abrasions or corrosions as well as the detection of foreign bodies.

Dosage & Administration

DIRECTIONS FOR USE To ensure optimal staining and patient comfort, the GloStrip impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application. Shake off excess solution and touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

Contraindications

CONTRAINDICATIONS Known hypersensitivity to Rose Bengal.

Frequently Asked Questions

What is GloStrips used for?

GloStrips contains Fluorescein Sodium. It is a strip taken ophthalmic. Consult your doctor for specific uses.

Is GloStrips a controlled substance?

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

What is the generic name for GloStrips?

The generic name for GloStrips is Fluorescein Sodium. There are 7 other brand versions of Fluorescein Sodium.

What is the NDC code for GloStrips 1 mg/1?

The NDC (National Drug Code) for GloStrips 1 mg/1 is 51801-009, listed by Nomax Inc..