Home / Recalls / Direct Rx / D-0485-2023

D-0485-2023 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
30 count: 5 bottles; 90 count: 53 bottles

Product Description

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, 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: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 .

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  • D-0507-2023 Class II — Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed B (March 22, 2023)
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  • D-0509-2023 Class II — Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: (March 22, 2023)
  • D-0483-2023 Class II — Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6191 (March 13, 2023)
  • D-0482-2023 Class II — Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 6 (March 13, 2023)
  • D-0481-2023 Class II — Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 6 (March 13, 2023)