FDAFDA · Food and drugs·Recall number D-0856-2017
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
Published May 31, 2017 · Recall initiated: February 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sato Pharmaceutical Inc.
- Distributor
- US: Hawaii, Guam, Saipan, SPI
- Lot
- Lot #: WXTZ, Exp. Sep 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.