D-0855-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- February 16, 2017
- Termination Date
- March 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,790 bottles
Product Description
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Reason for Recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Distribution Pattern
US: Hawaii, Guam, Saipan, SPI
Code Information
Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019