Medications & Supplements/Prescription Drugs

Montelukast, Simvastatin, and Glimepiride Recalled for Manufacturing Deviations

Agency Publication Date: May 1, 2023

Summary

PD-Rx Pharmaceuticals, Inc. is recalling approximately 1,488 bottles of Montelukast Sodium, Simvastatin, and Glimepiride across multiple strengths. This recall was initiated due to manufacturing deviations (CGMP deviations) that occurred during the production process at the manufacturing facility. These prescription medications, which are used to treat asthma, high cholesterol, and type 2 diabetes, were distributed nationwide to physician offices and clinics. To date, no injuries or adverse health events have been reported related to this issue.

Risk

The manufacturing deviations mean the medications may not meet safety and quality standards, which could potentially result in products that do not work as intended or pose unforeseen risks to patients. While no injuries have been reported, using medication that does not meet manufacturing requirements can lead to complications in managing chronic health conditions.

What You Should Do

This recall affects Montelukast Sodium USP (10 mg), Simvastatin USP (10 mg, 20 mg, 40 mg), and Glimepiride USP (4 mg) packaged by PD-Rx Pharmaceuticals, Inc. and distributed nationwide in 30-count and 90-count bottles.
To determine if your medication is affected, check the bottle label for the NDC code and lot number printed on the packaging. See the Affected Products section below for the full list of affected codes.
If you have health concerns or are unsure if your medication is safe to use, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact PD-Rx Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this safety alert.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Montelukast Sodium USP (10 mg)

Variants: 30-count bottle, Tablet

Lot Numbers:

L22C80 (Exp. 11/30/23)

I22D93 (Exp. 11/30/23)

K21C72 (Exp. 11/30/23)

A23A90 (Exp. 07/31/24)

B23A09 (Exp. 07/31/24)

K22C33 (Exp. 05/31/24)

G22E88 (Exp. 02/28/24)

G22F66 (Exp. 02/28/24)

I22E27 (Exp. 02/28/24)

C22B27 (Exp. 02/28/24)

D22B94 (Exp. 02/28/24)

E22C71 (Exp. 02/28/24)

I21E36 (Exp. 09/30/23)

NDC:

43063-0762-30

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm, Limited India

Product: Simvastatin USP (10 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

K22E32 (Exp. 10/31/23)

H22C33 (Exp. 09/30/23)

H22C81 (Exp. 10/31/23)

J22C83 (Exp. 10/31/23)

K22E36 (Exp. 10/31/23)

NDC:

43063-0727-30

43063-0727-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm, Limited India

Product: Glimepiride USP (4 mg)

Variants: 90-count bottle, Tablet

Lot Numbers:

A22B45 (Exp. 01/31/24)

C22A73 (Exp. 03/31/24)

E22E41 (Exp. 03/31/24)

C22D28 (Exp. 03/31/24)

F22B68 (Exp. 03/31/24)

G22A29 (Exp. 03/31/24)

H22B97 (Exp. 03/31/24)

K22A36 (Exp. 03/31/24)

K22B99 (Exp. 10/31/24)

A23D07 (Exp. 10/31/24)

B23B25 (Exp. 10/31/24)

B23B55 (Exp. 06/30/25)

NDC:

43063-0587-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited

Product: Simvastatin USP (20 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

G22B32 (Exp. 06/30/23)

D22B92 (Exp. 06/30/23)

D22F82 (Exp. 06/30/23)

G22F41 (Exp. 01/31/24)

J22F25 (Exp. 01/31/24)

L22C14 (Exp. 01/31/24)

B22A12 (Exp. 03/31/23)

H22A32 (Exp. 01/31/24)

I22E83 (Exp. 01/31/24)

J22E94 (Exp. 01/31/24)

K22E34 (Exp. 01/31/24)

C22F31 (Exp. 06/30/23)

D22G16 (Exp. 06/30/23)

E22D75 (Exp. 06/30/23)

F22E06 (Exp. 06/30/23)

L21E09 (Exp. 01/31/23)

B22C61 (Exp. 01/31/23)

NDC:

43063-008-30

43063-0008-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited India

Product: Simvastatin USP (40 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

A22A17 (Exp. 07/31/23)

D22C21 (Exp. 07/31/23)

K22D89 (Exp. 03/31/24)

L22B26 (Exp. 03/31/24)

L22D14 (Exp. 03/31/24)

L22D96 (Exp. 04/30/24)

L21E06 (Exp. 05/31/23)

B22C05 (Exp. 07/31/23)

D22B91 (Exp. 07/31/23)

E22C82 (Exp. 07/31/23)

G22B03 (Exp. 08/31/23)

G22B79 (Exp. 08/31/23)

H22A30 (Exp. 08/31/23)

J22B81 (Exp. 08/31/23)

J22F27 (Exp. 10/31/23)

K22B37 (Exp. 10/31/23)

K22B88 (Exp. 10/31/23)

L22D32 (Exp. 03/31/24)

B23E07 (Exp. 04/30/24)

NDC:

43063-0726-30

43063-0726-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92081

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Physician offices; Clinics

Manufactured In: United States, India

Units Affected: 5 products (352 bottles; 37 bottles; 186 bottles; 520 bottles; 393 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Montelukast Sodium USP (10 mg), Simvastatin USP (10 mg, 20 mg, 40 mg), and Glimepiride USP (4 mg) packaged by PD-Rx Pharmaceuticals, Inc. and distributed nationwide in 30-count and 90-count bottles.

To determine if your medication is affected, check the bottle label for the NDC code and lot number printed on the packaging. See the Affected Products section below for the full list of affected codes.

If you have health concerns or are unsure if your medication is safe to use, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact PD-Rx Pharmaceuticals, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this safety alert.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Montelukast Sodium USP (10 mg)

Variants: 30-count bottle, Tablet

Lot Numbers:

L22C80 (Exp. 11/30/23)

I22D93 (Exp. 11/30/23)

K21C72 (Exp. 11/30/23)

A23A90 (Exp. 07/31/24)

B23A09 (Exp. 07/31/24)

K22C33 (Exp. 05/31/24)

G22E88 (Exp. 02/28/24)

G22F66 (Exp. 02/28/24)

I22E27 (Exp. 02/28/24)

C22B27 (Exp. 02/28/24)

D22B94 (Exp. 02/28/24)

E22C71 (Exp. 02/28/24)

I21E36 (Exp. 09/30/23)

NDC:

43063-0762-30

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm, Limited India

Product: Simvastatin USP (10 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

K22E32 (Exp. 10/31/23)

H22C33 (Exp. 09/30/23)

H22C81 (Exp. 10/31/23)

J22C83 (Exp. 10/31/23)

K22E36 (Exp. 10/31/23)

NDC:

43063-0727-30

43063-0727-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm, Limited India

Product: Glimepiride USP (4 mg)

Variants: 90-count bottle, Tablet

Lot Numbers:

A22B45 (Exp. 01/31/24)

C22A73 (Exp. 03/31/24)

E22E41 (Exp. 03/31/24)

C22D28 (Exp. 03/31/24)

F22B68 (Exp. 03/31/24)

G22A29 (Exp. 03/31/24)

H22B97 (Exp. 03/31/24)

K22A36 (Exp. 03/31/24)

K22B99 (Exp. 10/31/24)

A23D07 (Exp. 10/31/24)

B23B25 (Exp. 10/31/24)

B23B55 (Exp. 06/30/25)

NDC:

43063-0587-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited

Product: Simvastatin USP (20 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

G22B32 (Exp. 06/30/23)

D22B92 (Exp. 06/30/23)

D22F82 (Exp. 06/30/23)

G22F41 (Exp. 01/31/24)

J22F25 (Exp. 01/31/24)

L22C14 (Exp. 01/31/24)

B22A12 (Exp. 03/31/23)

H22A32 (Exp. 01/31/24)

I22E83 (Exp. 01/31/24)

J22E94 (Exp. 01/31/24)

K22E34 (Exp. 01/31/24)

C22F31 (Exp. 06/30/23)

D22G16 (Exp. 06/30/23)

E22D75 (Exp. 06/30/23)

F22E06 (Exp. 06/30/23)

L21E09 (Exp. 01/31/23)

B22C61 (Exp. 01/31/23)

NDC:

43063-008-30

43063-0008-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited India

Product: Simvastatin USP (40 mg)

Variants: 30-count bottle, 90-count bottle, Tablet

Lot Numbers:

A22A17 (Exp. 07/31/23)

D22C21 (Exp. 07/31/23)

K22D89 (Exp. 03/31/24)

L22B26 (Exp. 03/31/24)

L22D14 (Exp. 03/31/24)

L22D96 (Exp. 04/30/24)

L21E06 (Exp. 05/31/23)

B22C05 (Exp. 07/31/23)

D22B91 (Exp. 07/31/23)

E22C82 (Exp. 07/31/23)

G22B03 (Exp. 08/31/23)

G22B79 (Exp. 08/31/23)

H22A30 (Exp. 08/31/23)

J22B81 (Exp. 08/31/23)

J22F27 (Exp. 10/31/23)

K22B37 (Exp. 10/31/23)

K22B88 (Exp. 10/31/23)

L22D32 (Exp. 03/31/24)

B23E07 (Exp. 04/30/24)

NDC:

43063-0726-30

43063-0726-90

Pkg By: PD-Rx Pharmaceuticals Incorporated; Mfr: Intas Pharm. Limited India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92081

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Physician offices; Clinics

Manufactured In: United States, India

Units Affected: 5 products (352 bottles; 37 bottles; 186 bottles; 520 bottles; 393 bottles)

Distributed To: Nationwide