D-0856-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- February 16, 2017
- Termination Date
- March 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,325 bottles
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
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 #: WXTZ, Exp. Sep 2019