Recalls / Class III
Class IIID-0961-2015
Product
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.
- Brand name
- Glostrips
- Generic name
- Fluorescein Sodium
- Active ingredient
- Fluorescein Sodium
- Route
- Ophthalmic
- NDC
- 51801-003
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Nomax Inc
- Manufacturer
- Nomax Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9735 Green Park Industrial Dr, Saint Louis, Missouri 63123-7241
Distribution
- Quantity
- 23,201 cartons
- Distribution pattern
- Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Timeline
- Recall initiated
- 2015-03-24
- FDA classified
- 2015-04-21
- Posted by FDA
- 2015-04-29
- Terminated
- 2017-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0961-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.