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Class II: temporary or reversible health riskTerminated

PD-Rx Pharmaceuticals Glimepiride Recall

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm

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

Risk level
Class II
Reported by FDA
May 10, 2023
Recall ID
D-0559-2023
Check your lot numberHow we source this data

Summary

PD-Rx Pharmaceuticals recalled Glimepiride starting Apr 6, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0559-2023 on May 10, 2023. Reason: CGMP deviations. Status: Terminated.

Why it was recalled

CGMP deviations.

Product description

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

Lot numbers, UPCs & expiration codes

Lots: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25

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-0559-2023
Classification
Class II
Status
Terminated
Recall initiated
Apr 6, 2023
FDA report date
May 10, 2023
Quantity
186 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0559-2023, 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: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25
Postal code
73127-5822
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0559-2023
Classification
Class II
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Product quantity
186 bottles
Termination date
Apr 30, 2024
Reason for recall
CGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
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-0559-2023, 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.

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