Multi-event February 2017 FDA Recall Drug by Sato Pharmaceutical Inc.

This Multi-event Class II drug recall was voluntarily initiated by Sato Pharmaceutical Inc. on February 16, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in US: Hawaii, Guam, Saipan, SPI and the recall is currently terminated.

Reported Recall Events

D-0855-2017 TERMINATED D-0854-2017 TERMINATED D-0856-2017 TERMINATED

Recall Number: D-0855-2017

Reason for Recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Initiated
02-16-2017
Reported
05-31-2017
Quantity
4,790 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77161
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sato Pharmaceutical Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: Hawaii, Guam, Saipan, SPI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : WXWZ, Exp. March 2019; WXTS, Exp. October 2019

Recall Number: D-0854-2017

Reason for Recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Initiated
02-16-2017
Reported
05-31-2017
Quantity
10,130 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77161
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sato Pharmaceutical Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: Hawaii, Guam, Saipan, SPI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2018
Product Description About Product Description
Full technical description of the product.
Optic Splash (naphazoline hydrochloride) 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 49873-501-01.

Batch or Lot Expiration Information

Lot# : XXWC, Exp. August 2018

Recall Number: D-0856-2017

Reason for Recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Initiated
02-16-2017
Reported
05-31-2017
Quantity
14,325 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77161
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sato Pharmaceutical Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: Hawaii, Guam, Saipan, SPI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : WXTZ, Exp. Sep 2019