Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually w...

FDA Drug Recall #D-0963-2015 — Class III — March 24, 2015

Recall Summary

Recall Number D-0963-2015
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 62,691 cartons

Product Description

Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123.

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) FUL-GLO Lot: 8980, Exp 10/15; 9081, Exp 01/16; 9088, Exp 02/16; 9128 and 9158, Exp 03/16; 2) Pro Glo Lot: 9082, Exp 01/17

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.