Drug 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
D-0856-2017
Product summary
- Event
- Event 77161
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,325 bottles
- Official record key
drug-enforcement:D-0856-2017
Official wording
Reason: Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Code information: Lot #: WXTZ, Exp. Sep 2019
Distribution pattern: US: Hawaii, Guam, Saipan, SPI
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility