GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Reported: May 1, 2024 Initiated: April 19, 2024 #D-0462-2024
Product Description
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Reason for Recall
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.
Details
- Recalling Firm
- Nomax Inc
- Units Affected
- 15,056 cartons
- Distribution
- Nationwide in the USA
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.. Recalled by Nomax Inc. Units affected: 15,056 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2024. Severity: Moderate. Recall number: D-0462-2024.
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