Recalls / Class II
Class IID-0481-2023
Product
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
- Affected lot / code info
- 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 .
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 30 count: 12 bottles; 90 count: 253 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-13
- FDA classified
- 2023-03-24
- Posted by FDA
- 2023-04-05
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0481-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.