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
Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
Lot numbers, UPCs & expiration codes
Lot #: XXWC, Exp. August 2018
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-0854-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2017
- FDA report date
- May 31, 2017
- Quantity
- 10,130 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sato Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0854-2017, 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 #: XXWC, Exp. August 2018
- Postal code
- 90501-1834
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0854-2017
- Classification
- Class II
- Recalling firm
- Sato Pharmaceutical Inc.
- Product quantity
- 10,130 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
- Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
- Distribution pattern
- US: Hawaii, Guam, Saipan, SPI
- Recall initiation date
- Feb 16, 2017
- Initial firm notification
- Letter
- Center classification date
- May 23, 2017