Medications & Supplements/Prescription Drugs

GSMS Rifampin Capsules Recalled for Impurity Above Interim Limit

Agency Publication Date: October 17, 2022

Summary

Golden State Medical Supply Inc. (GSMS) has recalled Rifampin Capsules (150 mg and 300 mg) because testing revealed levels of an impurity known as 1-Methyl-4-Nitrosopoperazine (MNP) that exceed acceptable interim limits. Rifampin is an antibiotic used to treat tuberculosis and other bacterial infections. While no illnesses or injuries have been reported to date, the product was distributed nationwide across the United States to pharmacies and healthcare facilities. Consumers who are currently taking this medication should contact their healthcare provider to discuss alternative treatments.

Risk

MNP is a nitrosamine impurity, and long-term exposure to these substances at levels above recommended limits may increase the risk of developing cancer.

What You Should Do

This recall affects Rifampin Capsules (150 mg and 300 mg) sold in 30, 60, and 100-count bottles under the Golden State Medical Supply (GSMS) brand label.
Check your medication bottle for NDC codes 51407-323-30, 51407-323-60, 51407-323-01, or 51407-322-30. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Rifampin Capsules, USP, 300 mg

Variants: 300 mg, 30-count bottle, 60-count bottle, 100-count bottle, Rx only

Lot Numbers:

GS041430 (Exp 1/31/2023)

GS041941 (Exp 1/31/2023)

GS041315 (Exp 3/31/2023)

GS042991 (Exp 3/31/2023)

GS043027 (Exp 3/31/2023)

GS043367 (Exp 3/31/2023)

GS043501 (Exp 3/31/2023)

GS044421 (Exp 3/31/2023)

GS041431 (Exp 1/31/2023)

GS041799 (Exp 1/31/2023)

GS042287 (Exp 1/31/2023)

GS042414 (Exp 1/31/2023)

GS042879 (Exp 1/31/2023)

GS041316 (Exp 3/31/2023)

GS042992 (Exp 3/31/2023)

GS043368 (Exp 3/31/2023)

GS043579 (Exp 3/31/2023)

GS041429 (Exp 1/31/2023)

GS041877 (Exp 1/31/2023)

GS041317 (Exp 3/31/2023)

GS043028 (Exp 3/31/2023)

GS043366 (Exp 3/31/2023)

GS044422 (Exp 3/31/2023)

NDC:

51407-323-30

51407-323-60

51407-323-01

Packaged by GSMS, Incorporated, CA; Manufactured by Patheon Pharmaceuticals Inc., OH.

Product: Rifampin Capsules, USP, 150 mg

Variants: 150 mg, 30-count bottle, Rx only

Lot Numbers:

GS036715 (Exp 10/31/2022)

GS037569 (Exp 10/31/2022)

GS038132 (Exp 10/31/2022)

GS038665 (Exp 10/31/2022)

GS038750 (Exp 10/31/2022)

GS039565 (Exp 10/31/2022)

GS039997 (Exp 10/31/2022)

GS040673 (Exp 10/31/2022)

GS040674 (Exp 3/31/2023)

GS041237 (Exp 3/31/2023)

GS041652 (Exp 3/31/2023)

GS042152 (Exp 3/31/2023)

GS043365 (Exp 3/31/2023)

GS045441 (Exp 2/29/2024)

GS045677 (Exp 2/29/2024)

GS046111 (Exp 2/29/2024)

NDC:

51407-322-30

Packaged by GSMS, Incorporated, CA; Manufactured by Patheon Pharmaceuticals Inc., OH.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90992

Status: Resolved

Manufacturer: Golden State Medical Supply Inc.

Sold By: pharmacies

Manufactured In: United States

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

What You Should Do

This recall affects Rifampin Capsules (150 mg and 300 mg) sold in 30, 60, and 100-count bottles under the Golden State Medical Supply (GSMS) brand label.

Check your medication bottle for NDC codes 51407-323-30, 51407-323-60, 51407-323-01, or 51407-322-30. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Rifampin Capsules, USP, 300 mg

Variants: 300 mg, 30-count bottle, 60-count bottle, 100-count bottle, Rx only

Lot Numbers:

GS041430 (Exp 1/31/2023)

GS041941 (Exp 1/31/2023)

GS041315 (Exp 3/31/2023)

GS042991 (Exp 3/31/2023)

GS043027 (Exp 3/31/2023)

GS043367 (Exp 3/31/2023)

GS043501 (Exp 3/31/2023)

GS044421 (Exp 3/31/2023)

GS041431 (Exp 1/31/2023)

GS041799 (Exp 1/31/2023)

GS042287 (Exp 1/31/2023)

GS042414 (Exp 1/31/2023)

GS042879 (Exp 1/31/2023)

GS041316 (Exp 3/31/2023)

GS042992 (Exp 3/31/2023)

GS043368 (Exp 3/31/2023)

GS043579 (Exp 3/31/2023)

GS041429 (Exp 1/31/2023)

GS041877 (Exp 1/31/2023)

GS041317 (Exp 3/31/2023)

GS043028 (Exp 3/31/2023)

GS043366 (Exp 3/31/2023)

GS044422 (Exp 3/31/2023)

NDC:

51407-323-30

51407-323-60

51407-323-01

Packaged by GSMS, Incorporated, CA; Manufactured by Patheon Pharmaceuticals Inc., OH.

Product: Rifampin Capsules, USP, 150 mg

Variants: 150 mg, 30-count bottle, Rx only

Lot Numbers:

GS036715 (Exp 10/31/2022)

GS037569 (Exp 10/31/2022)

GS038132 (Exp 10/31/2022)

GS038665 (Exp 10/31/2022)

GS038750 (Exp 10/31/2022)

GS039565 (Exp 10/31/2022)

GS039997 (Exp 10/31/2022)

GS040673 (Exp 10/31/2022)

GS040674 (Exp 3/31/2023)

GS041237 (Exp 3/31/2023)

GS041652 (Exp 3/31/2023)

GS042152 (Exp 3/31/2023)

GS043365 (Exp 3/31/2023)

GS045441 (Exp 2/29/2024)

GS045677 (Exp 2/29/2024)

GS046111 (Exp 2/29/2024)

NDC:

51407-322-30

Packaged by GSMS, Incorporated, CA; Manufactured by Patheon Pharmaceuticals Inc., OH.