Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Product Codes/Lot Numbers:
a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0484-2023
Related Recalls
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle