GloStrips
Fluorescein Sodium · Strip · Ophthalmic
Uses
For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.
Dosage forms and strengths
To ensure full fluorescence and patient comfort, the GloStrip ® impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application. NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.
How supplied
Carton containing 100 or 300 sterile strips.
Label text from the FDA structured product label by Nomax Inc. (revised Dec 23, 2019). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fluorescein Sodium in 2 products
- Rose Bengal Sodium in 1 product
GloStrips NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 51801-003 | Fluorescein Sodium .6 mg/1 Strip | Nomax Inc. | UNAPPROVED DRUG OTHER |
| 51801-004 | Rose Bengal Sodium 1.3 mg/1 Strip | Nomax Inc. | UNAPPROVED DRUG OTHER |
| 51801-009 | Fluorescein Sodium 1 mg/1 Strip | Nomax Inc. | UNAPPROVED DRUG OTHER |
GloStrips recalls
- D-0462-2024 May 1, 2024 · Class II · Ongoing
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. - D-0463-2024 May 1, 2024 · Class II · Ongoing
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. - D-0961-2015 Apr 29, 2015 · Class III · Terminated
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… - D-0962-2015 Apr 29, 2015 · Class III · Terminated
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…
Frequently asked questions
What is GloStrips used for?
For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.
Who makes GloStrips?
GloStrips is listed by 1 labeler in the FDA NDC directory, including Nomax Inc..
Has GloStrips been recalled?
The FDA enforcement database lists 4 recalls for GloStrips, most recently D-0462-2024 (class ii): Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP…