Drug Enforcement D-0483-2023

cGMP deviations

Status

Terminated

Classification

Class II

Report Date

April 5, 2023

Termination Date

June 17, 2024

Product Information

Product description
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Product quantity
51 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-0483-2023
Event ID
91921
Recall initiation date
March 13, 2023
Center classification date
March 24, 2023
Code info
Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23
More code info
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