Drug Enforcement D-0101-2023

cGMP deviation: discontinue of stability support for product.

Status

Terminated

Classification

Class II

Report Date

January 18, 2023

Termination Date

September 30, 2024

Product Information

Product description
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Product quantity
11 bottles
Reason for recall
cGMP deviation: discontinue of stability support for product.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
FL

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0101-2023
Event ID
91114
Recall initiation date
November 2, 2022
Center classification date
January 11, 2023
Code info
Lot #: 07MA2232, Exp. 4/30/23
More code info
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