Drug product
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
D-0216-2017
Product summary
- Event
- Event 74878
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,744 bottles
- Official record key
drug-enforcement:D-0216-2017
Official wording
Reason: Non Sterility; contaminated with Klebsiella pneumoniae
Code information: Lot number: F16091-61, exp 03/2019 Product Codes: 32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, 32-000462-0036
Distribution pattern: Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
Derived failure modes
-
Unknown
Non Sterility; contaminated with Klebsiella pneumoniae