Why it was recalled
CGMP Deviations
Product description
Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
Lot numbers, UPCs & expiration codes
Lot #: a) 20171215 and 20171016, b) 20171016
Where it was sold
NY and CA.
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-1049-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 14,400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Longbow First Aid Products Manufactory
Original FDA data
Every field from FDA enforcement report D-1049-2018, exactly as published.
Show all FDA fields
- City
- Foshan
- Status
- Terminated
- Country
- China
- Event ID
- 80614
- Address
- Building F/2
- Address (line 2)
- A3 Guiping Road; Hantian Industrial Park
- Code information
- Lot #: a) 20171215 and 20171016, b) 20171016
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1049-2018
- Classification
- Class II
- Recalling firm
- Longbow First Aid Products Manufactory
- Product quantity
- 14,400 bottles
- Termination date
- Sep 11, 2019
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
- Distribution pattern
- NY and CA.
- Recall initiation date
- Jul 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2018