Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Fluorescein Sodium Ophthalmic Strips USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045.
Affected NDCs
1748-0403-03
17478-0403
17478-0403-03
51801-0003-01
51801-0003-40
51801-0003-50
Compare with the code on your package — it is the most precise check available.
Drug: Fluorescein Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| GloStrips Fluorescein Sodium NDC 51801-0003 |
.6 mg/1 | Strip Ophthalmic |
Nomax Inc. | Rx |
- Recalling firm
- Nomax Inc
- NDC code
- 51801-003-01
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0961-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluorescein recalls
See all
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class II · Moderate risk
Ful-Glo
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.
Other recalls by Nomax Inc
All 2015 recalls
Class II · Moderate risk
Ful-Glo
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.
Class II · Moderate risk
Ful-Glo
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.
Class II · Moderate risk
GloStrips
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.
Class II · Moderate risk
GloStrips
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.
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