Class II Recall

Direct Rx

Product
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason
cGMP deviations
Classification
Class II
Status
Terminated
Lot
a) [30 count bottles] Lot, expiry: 13DE2111 , exp 3/31/2024 b) [90 count bottles] Lot, expiry: 17NO2116 , exp 1/31/2024 ; 27JA2234 , exp 4/30/2024; 02MA2218, exp 6/30/2024 ; 12MY2211, exp 7/31/2024 ; 13JY2107, exp 10/31/2023; 15AP2221 , exp 7/31/2024 ; 17AU2110 , exp 10/31/2023; 20SE2108 , exp 10/31/2023; 23JU2115 , exp 10/31/2023; 28JY2101 ,exp 10/31/2023; 30JY2101 ,exp 10/31/2023; 05JA2212 , exp 3/31/2024 ; 13DE2130 , exp 3/31/2024 ; 21OC2111, exp 1/31/2024 ; 17NO2116 , exp 3/31/2024 .
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.