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

Class I - Dangerous
💊 Drugs Recalled: March 13, 2023 Direct Rx Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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 .
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Direct Rx
Reason for Recall:
cGMP deviations
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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 .

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0482-2023

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