Class II
Terminated
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
- Company
- Sato Pharmaceutical Inc.
- Recall Initiated
- February 16, 2017
- Posted
- May 31, 2017
- Recall Number
- D-0856-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,325 bottles
- Firm Location
- Torrance, CA, United States
Reason for Recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Distribution
US: Hawaii, Guam, Saipan, SPI
Lot / Code Info
Lot #: WXTZ, Exp. Sep 2019
More recalls by Sato Pharmaceutical Inc.
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