D-0854-2017 Class II Terminated
FDA drug recall D-0854-2017 was initiated by Sato Pharmaceutical Inc. on Feb 16, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. The recall status is terminated (terminated Mar 13, 2018). Affected quantity: 10,130 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- Feb 16, 2017
- Termination Date
- Mar 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,130 bottles
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.
Reason for recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Distribution pattern
US: Hawaii, Guam, Saipan, SPI
Code information
Lot #: XXWC, Exp. August 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0854-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026