FDA Drug recall D-0856-2017
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-2…
- FDA Drug
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-2… by Sato Pharmaceutical, citing lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0856-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-16 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sato Pharmaceutical |
| Distribution | HI |
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
Reason
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Identifiers
| code_info | Lot #: WXTZ, Exp. Sep 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.