Drug Enforcement D-0478-2023

cGMP deviations

Status

Terminated

Classification

Class II

Report Date

April 5, 2023

Termination Date

June 17, 2024

Product Information

Product description
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Product quantity
9 bottles
Reason for recall
cGMP deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr, N/A

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

Codes & Dates

Recall number
D-0478-2023
Event ID
91921
Recall initiation date
March 13, 2023
Center classification date
March 24, 2023
Code info
Lot, expiry: 21JU2210, exp 7/31/23
More code info
—