Drug product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
D-040-2013
Product summary
- Event
- Event 35255
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2470 kits
- Official record key
drug-enforcement:D-040-2013
Official wording
Reason: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Code information: All convenience kits containing Part Number 8118, all lot numbers.
Distribution pattern: Connecticut, Maryland, Ohio, and South Carolina.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility