FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

PD-Rx Pharmaceuticals Simvastatin Recall

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: P…

PD-Rx Pharmaceuticals, Inc. · Oklahoma City, OK

Risk level
Class II
Reported by FDA
May 10, 2023
Recall ID
D-0558-2023
Check your lot numberHow we source this data

Summary

PD-Rx Pharmaceuticals recalled Simvastatin starting Apr 6, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0558-2023 on May 10, 2023. Reason: CGMP deviations. Status: Terminated.

Why it was recalled

CGMP deviations.

Product description

Simvastatin USP, 10 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 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

Lot numbers, UPCs & expiration codes

Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23

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-0558-2023
Classification
Class II
Status
Terminated
Recall initiated
Apr 6, 2023
FDA report date
May 10, 2023
Quantity
37 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0558-2023, 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) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23
Postal code
73127-5822
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0558-2023
Classification
Class II
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Product quantity
37 bottles
Termination date
Apr 30, 2024
Reason for recall
CGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Simvastatin USP, 10 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 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
Distribution pattern
Nationwide in the US.
Recall initiation date
Apr 6, 2023
Initial firm notification
Letter
Center classification date
May 1, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0558-2023, published May 10, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls