Why it was recalled
Non Sterility; contaminated with Klebsiella pneumoniae
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
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-0216-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 16, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 9,744 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sperian Eye & Face Protection, Inc
Original FDA data
Every field from FDA enforcement report D-0216-2017, exactly as published.
Show all FDA fields
- City
- Platteville
- State
- WI
- Status
- Terminated
- Country
- United States
- Event ID
- 74878
- Address
- 825 E Business Highway 151
- 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
- Postal code
- 53818-3763
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0216-2017
- Classification
- Class I
- Recalling firm
- Sperian Eye & Face Protection, Inc
- Product quantity
- 9,744 bottles
- Termination date
- May 30, 2019
- Reason for recall
- Non Sterility; contaminated with Klebsiella pneumoniae
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
- Recall initiation date
- Aug 16, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 22, 2016