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.
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.
Lot numbers, UPCs & expiration codes
Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
Where it was sold
Nationwide, Puerto Rico, Canada, and Hong Kong.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1411-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 10, 2014
- FDA report date
- Jul 2, 2014
- Quantity
- 35,253 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb, Inc.
Original FDA data
Every field from FDA enforcement report D-1411-2014, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 68348
- Address
- 8500 Hidden River Pkwy
- Code information
- Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15
- Postal code
- 33637-1014
- Report date
- Jul 2, 2014
- Product type
- Drugs
- Recall number
- D-1411-2014
- Classification
- Class II
- Recalling firm
- Bausch & Lomb, Inc.
- Product quantity
- 35,253 tubes
- Termination date
- Apr 14, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide, Puerto Rico, Canada, and Hong Kong.
- Recall initiation date
- Apr 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2014