DORAMA-NEO — Class II drug recall D-0856-2017
Terminated recall by Sato Pharmaceutical Inc., reported 2017-05-31, distributed in GU, HI. Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental condi
| Recall number | D-0856-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sato Pharmaceutical Inc., Torrance, CA, United States |
| Recall initiated | 2017-02-16 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-03-13 |
| Distributed | GU, HI |
| Quantity | 14,325 bottles |
| Reason classes | sterility |
| NDC | 49873-0020-01 |
| Expiration dates | 2019-09-20 |
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 for recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0856-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.