Why it was recalled
CGMP Deviations
Product description
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
Lot numbers, UPCs & expiration codes
Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
Where it was sold
Nationwide USA, Canada
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-0461-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 29, 2024
- FDA report date
- May 1, 2024
- Quantity
- 10, 605 cartridges
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HONEYWELL INC
Original FDA data
Every field from FDA enforcement report D-0461-2024, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 94345
- Address
- 855 S Mint St
- Code information
- Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
- Postal code
- 28202
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0461-2024
- Classification
- Class II
- Recalling firm
- HONEYWELL INC
- Product quantity
- 10, 605 cartridges
- Termination date
- Sep 30, 2024
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
- Distribution pattern
- Nationwide USA, Canada
- Recall initiation date
- Mar 29, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2024