Why it was recalled
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Product description
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Lot numbers, UPCs & expiration codes
Lot #: WXTZ, Exp. Sep 2019
Where it was sold
US: Hawaii, Guam, Saipan, SPI
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-0856-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2017
- FDA report date
- May 31, 2017
- Quantity
- 14,325 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sato Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0856-2017, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77161
- Address
- 20695 S Western Ave Ste 240
- Code information
- Lot #: WXTZ, Exp. Sep 2019
- Postal code
- 90501-1834
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0856-2017
- Classification
- Class II
- Recalling firm
- Sato Pharmaceutical Inc.
- Product quantity
- 14,325 bottles
- Termination date
- Mar 13, 2018
- Reason for recall
- Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
- Distribution pattern
- US: Hawaii, Guam, Saipan, SPI
- Recall initiation date
- Feb 16, 2017
- Initial firm notification
- Letter
- Center classification date
- May 23, 2017