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
Reported: May 31, 2017 Initiated: February 16, 2017 #D-0856-2017
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.
Details
- Recalling Firm
- Sato Pharmaceutical Inc.
- Units Affected
- 14,325 bottles
- Distribution
- US: Hawaii, Guam, Saipan, SPI
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sato Pharmaceutical Inc.. Units affected: 14,325 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Moderate. Recall number: D-0856-2017.
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