Recalls / Class II
Class IID-0480-2023
Product
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Affected lot / code info
- a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/2024; 28JY2102 , exp 1/31/2024; 06AU2103 , exp 1/31/2024 ; 03JA2210 , exp 1/31/2024 ; 14JY2114 , exp 1/31/2024 ; 05NO2106 , exp 2/29/2024 ; 13OC2118 , exp 2/29/2024 ; 08DE2121 , exp 2/29/2024 ;
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: 4 bottles; 90 count: 172 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-0480-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.