Why it was recalled
Non-Sterility: Product manufactured under non-sterile production conditions.
Product description
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Lot numbers, UPCs & expiration codes
All lots, no expiration dates are on the bottles.
Where it was sold
Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
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-0250-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 5, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 18,521 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kadesh International
Original FDA data
Every field from FDA enforcement report D-0250-2019, exactly as published.
Show all FDA fields
- City
- Garden Grove
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 81512
- Address
- 9618 Garden Grove Blvd Ste 201
- Code information
- All lots, no expiration dates are on the bottles.
- Postal code
- 92844-1565
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0250-2019
- Classification
- Class I
- Recalling firm
- Kadesh International
- Product quantity
- 18,521 bottles
- Termination date
- Jan 24, 2023
- Reason for recall
- Non-Sterility: Product manufactured under non-sterile production conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
- Distribution pattern
- Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
- Recall initiation date
- Nov 5, 2018
- Initial firm notification
- Center classification date
- Nov 19, 2018