Why it was recalled
CGMP deviations.
Product description
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Lot numbers, UPCs & expiration codes
Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24
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-0561-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 6, 2023
- FDA report date
- May 10, 2023
- Quantity
- 393 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0561-2023, 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) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24
- Postal code
- 73127-5822
- Report date
- May 10, 2023
- Product type
- Drugs
- Recall number
- D-0561-2023
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 393 bottles
- Termination date
- Apr 30, 2024
- Reason for recall
- CGMP deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Apr 6, 2023
- Initial firm notification
- Letter
- Center classification date
- May 1, 2023