Recalls / Class II
Class IID-0856-2017
Product
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
- Affected lot / code info
- Lot #: WXTZ, Exp. Sep 2019
Why it was recalled
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Recalling firm
- Firm
- Sato Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20695 S Western Ave Ste 240, Torrance, California 90501-1834
Distribution
- Quantity
- 14,325 bottles
- Distribution pattern
- US: Hawaii, Guam, Saipan, SPI
Timeline
- Recall initiated
- 2017-02-16
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2018-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0856-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.