Recalls / Class III

Class IIID-0963-2015

Product

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.

Affected lot / code info

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

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

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

9735 Green Park Industrial Dr, Saint Louis, Missouri 63123-7241

Distribution

Quantity

62,691 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-0963-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.