D-1411-2014 Class II Terminated
FDA drug recall D-1411-2014 was initiated by Bausch & Lomb, Inc. on Apr 10, 2014 and is designated Class II. Reason for recall: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. The recall status is terminated (terminated Apr 14, 2017). Affected quantity: 35,253 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 2, 2014
- Initiation Date
- Apr 10, 2014
- Termination Date
- Apr 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,253 tubes
Product Description
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
Reason for Recall
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Distribution Pattern
Nationwide, Puerto Rico, Canada, and Hong Kong.
Code Information
Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1411-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026