Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, ...
FDA Drug Recall #D-0961-2015 — Class III — March 24, 2015
Recall Summary
| Recall Number | D-0961-2015 |
| Classification | Class III — Low risk |
| Date Initiated | March 24, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nomax Inc |
| Location | Saint Louis, MO |
| Product Type | Drugs |
| Quantity | 23,201 cartons |
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Lot / Code Information
1) GloStrips Lot: a) 9031, Exp 12/17; b) 9023, Exp 11/17; 9065, Exp 01/18; 9127 and 9132, Exp 03/18; and 2) Ful-Glo Lot: 9050, Exp 12/18; 9113, Exp 02/19; and 9206, Exp 05/19
Other Recalls from Nomax Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0462-2024 | Class II | GloStrips, Fluorescein Sodium Ophthalmic Strips... | Apr 19, 2024 |
| D-0465-2024 | Class II | FUL-GLO, Fluorescein Sodium Ophthalmic Strips U... | Apr 19, 2024 |
| D-0463-2024 | Class II | GloStrips, Fluorescein Sodium Ophthalmic Strips... | Apr 19, 2024 |
| D-0464-2024 | Class II | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic ... | Apr 19, 2024 |
| D-0387-2021 | Class III | Dry Eye Test, Fluorescein Sodium, Ophthalmic St... | Apr 13, 2021 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.