Recalls / Class II
Class IID-0462-2024
Product
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.
- Brand name
- Glostrips
- Generic name
- Fluorescein Sodium
- Active ingredient
- Fluorescein Sodium
- Route
- Ophthalmic
- NDC
- 51801-003
- Affected lot / code info
- Lot #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024
Why it was 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.
Recalling firm
- Firm
- Nomax Inc
- Manufacturer
- Nomax Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 9735 Green Park Industrial Dr, N/A, Saint Louis, Missouri 63123-7241
Distribution
- Quantity
- 15,056 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-04-19
- FDA classified
- 2024-04-23
- Posted by FDA
- 2024-05-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0462-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.