Recalls / Class II
Class IID-1411-2014
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.
- Affected lot / code info
- Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
Why it was recalled
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- 35,253 tubes
- Distribution pattern
- Nationwide, Puerto Rico, Canada, and Hong Kong.
Timeline
- Recall initiated
- 2014-04-10
- FDA classified
- 2014-06-25
- Posted by FDA
- 2014-07-02
- Terminated
- 2017-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1411-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.