Why it was recalled
CGMP deviations.
Product description
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
Lot numbers, UPCs & expiration codes
Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23.
Where it was sold
Nationwide in the US.
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-0560-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 6, 2023
- FDA report date
- May 10, 2023
- Quantity
- 520 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0560-2023, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 92081
- Address
- 727 N Ann Arbor Ave
- Code information
- Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23.
- Postal code
- 73127-5822
- Report date
- May 10, 2023
- Product type
- Drugs
- Recall number
- D-0560-2023
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 520 bottles
- Termination date
- Apr 30, 2024
- Reason for recall
- CGMP deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Apr 6, 2023
- Initial firm notification
- Letter
- Center classification date
- May 1, 2023