FDAFDA · Food and drugs·Recall number D-0481-2023
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Published April 5, 2023 · Recall initiated: March 13, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- Nationwide in the USA
- Lot
- a) [30 count bottles] Lot, expiry: 21JU2112 , exp 9/30/2023 b) [90 count bottles] Lot, expiry: 22DE2113 , exp 1/31/2024; 27JA2235 , exp 3/31/2024; 05AP2224 , exp 7/31/2024 ; 06AU2104 , exp 1/31/2024 ; 08JU2215 , exp 9/30/2024 ; 209AU2109 , exp 1/31/2024 ; 15JU2113 , exp 9/30/2023 ; 21FE2217 , exp 4/30/2024 ; 21OC2115 , exp 2/29/2024 ; 23JY2144 , exp 1/31/2024 ; 25JU2124 , exp 9/30/2023 ; 29AP2219 , exp 7/31/2024 ; 07DE2128 , exp 3/31/2024 .
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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