Recalls / Class III
Class IIID-0962-2015
Product
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.
- Brand name
- Glostrips
- Generic name
- Rose Bengal Sodium
- Active ingredient
- Rose Bengal Sodium
- Route
- Ophthalmic
- NDC
- 51801-004
- Affected lot / code info
- Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
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 rose bengal 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
- 5,514 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-0962-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.