Why it was recalled
cGMP deviations
Product description
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
Lot numbers, UPCs & expiration codes
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 .
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0481-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2023
- FDA report date
- Apr 5, 2023
- Quantity
- 30 count: 12 bottles; 90 count: 253 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0481-2023, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 91921
- Address
- 94 Worldwide Dr
- Code information
- 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 .
- Postal code
- 30534-6828
- Report date
- Apr 5, 2023
- Product type
- Drugs
- Recall number
- D-0481-2023
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 30 count: 12 bottles; 90 count: 253 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2023