Why it was recalled
cGMP deviations
Product description
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Lot numbers, UPCs & expiration codes
Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23
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-0483-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2023
- FDA report date
- Apr 5, 2023
- Quantity
- 51 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0483-2023, 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
- Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23
- Postal code
- 30534-6828
- Report date
- Apr 5, 2023
- Product type
- Drugs
- Recall number
- D-0483-2023
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 51 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 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