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Class II: temporary or reversible health riskTerminated

PD-Rx Pharmaceuticals Montelukast Sodium Recall

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedaba…

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

Risk level
Class II
Reported by FDA
May 10, 2023
Recall ID
D-0557-2023
Check your lot numberHow we source this data

Summary

PD-Rx Pharmaceuticals recalled Montelukast Sodium starting Apr 6, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0557-2023 on May 10, 2023. Reason: CGMP deviations. Status: Terminated.

Why it was recalled

CGMP deviations.

Product description

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

Lot numbers, UPCs & expiration codes

Lots: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23

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-0557-2023
Classification
Class II
Status
Terminated
Recall initiated
Apr 6, 2023
FDA report date
May 10, 2023
Quantity
352 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0557-2023, 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: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23
Postal code
73127-5822
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0557-2023
Classification
Class II
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Product quantity
352 bottles
Termination date
Apr 30, 2024
Reason for recall
CGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
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-0557-2023, 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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