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Recall Observatory FDA recall evidence

Drug product

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.

D-1411-2014

April 10, 2014

Class II

Product summary

Firm
Bausch & Lomb, Inc.
Event
Event 68348
Status
Terminated
Classification
Class II
Quantity
35,253 tubes
Official record key
drug-enforcement:D-1411-2014

Official wording

Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Code information: Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15

Distribution pattern: Nationwide, Puerto Rico, Canada, and Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.