October 2018 FDA Recall Drug by Promise Pharmacy Llc
D-0239-2019 - Presence of precipitate

This Class III drug recall was voluntarily initiated by Promise Pharmacy Llc on October 18, 2018 for the product Drug. The FDA reported the reason for recall as presence of precipitate. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0239-2019

Reason for Recall
Presence of precipitate
Initiated
10-18-2018
Reported
10-31-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81351
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Promise Pharmacy LLC
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.
U.S.A. Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-22-2020
Product Description About Product Description
Full technical description of the product.
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Batch or Lot Expiration Information

Lot# : 04092018@2, Exp 12/03/2018