Home / Recalls / Direct Rx / D-0476-2023

D-0476-2023 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
April 5, 2023
Initiation Date
March 13, 2023
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90 count: 495 bottles; 30 count: 13 bottles

Product Description

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide in the USA

Code Information

a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .

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