Glostrips Strip
FDA Recall NDC 51801-004
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glostrips (NDC 51801-004). A significant event, classified as Class III, was initiated on Mar 24, 2015 by Nomax Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Mar 24, 2015
Apr 29, 2015
5,514 cartons
Recall Profile & Regulatory Data
Event ID
70552
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Nomax Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Termination Date
Feb 21, 2017
Product Description
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.
Batch or Lot Expiration Information
Lot# : 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
Affected Packages Involved in this Recall
51801-004-40Product
51801-004-01Product
0035180100Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
