Medications & Supplements/Prescription Drugs

Sandoz Orphenadrine Citrate Tablets Recalled for Nitrosamine Impurity

Agency Publication Date: April 6, 2022

Summary

Sandoz, Inc. has recalled 7,908 bottles (approximately 790,800 tablets) of Orphenadrine Citrate Extended-Release Tablets (100 mg), a prescription medication used to treat muscle pain and stiffness. The recall was issued because the tablets may contain a nitrosamine impurity known as NMOA at levels that exceed the acceptable daily intake limit. No injuries or adverse events related to this issue have been reported to date. Consumers should consult their healthcare provider or pharmacist regarding their medication and the next steps for their treatment.

Risk

Nitrosamines are chemical compounds that may increase the risk of cancer if individuals are exposed to them above acceptable levels over long periods of time. The presence of NMOA above the daily limit in this medication poses a potential health risk to patients undergoing long-term treatment.

What You Should Do

This recall affects Sandoz Orphenadrine Citrate Extended-Release Tablets (100 mg), USP, Rx Only, sold in 100-count bottles with NDC 0185-0022-01.
Identify your product by checking the bottle for the following lot numbers and expiration dates: JX6411 (Exp. 05/2022), JX6413 (Exp. 05/2022), KC0723 (Exp. 08/2022), KC3303 (Exp. 08/2022), KE4348 (Exp. 11/2022), KE7169 (Exp. 11/2022), KE4349 (Exp. 11/2022), KL3199 (Exp. 03/2023), KM0072 (Exp. 03/2023), KS3939 (Exp. 03/2023), LA7704 (Exp. 11/2023), LA7703 (Exp. 11/2023), and LA9243 (Exp. 11/2023).
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 the manufacturer 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 additional information.

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: Orphenadrine Citrate Extended-Release Tablets (100 mg)by Sandoz

Variants: 100 mg, Extended-Release, Tablet

Lot Numbers:

JX6411 (Exp. 05/2022)

JX6413 (Exp. 05/2022)

KC0723 (Exp. 08/2022)

KC3303 (Exp. 08/2022)

KE4348 (Exp. 11/2022)

KE7169 (Exp. 11/2022)

KE4349 (Exp. 11/2022)

KL3199 (Exp. 03/2023)

KM0072 (Exp. 03/2023)

KS3939 (Exp. 03/2023)

LA7704 (Exp. 11/2023)

LA7703 (Exp. 11/2023)

LA9243 (Exp. 11/2023)

NDC:

0185-0022-01

Quantity: 7,908 bottles (790,800 tablets total)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88937

Status: Resolved

Manufacturer: Sandoz, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 7908 bottles(790,800 extended release tablets)

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 Sandoz Orphenadrine Citrate Extended-Release Tablets (100 mg), USP, Rx Only, sold in 100-count bottles with NDC 0185-0022-01.

Identify your product by checking the bottle for the following lot numbers and expiration dates: JX6411 (Exp. 05/2022), JX6413 (Exp. 05/2022), KC0723 (Exp. 08/2022), KC3303 (Exp. 08/2022), KE4348 (Exp. 11/2022), KE7169 (Exp. 11/2022), KE4349 (Exp. 11/2022), KL3199 (Exp. 03/2023), KM0072 (Exp. 03/2023), KS3939 (Exp. 03/2023), LA7704 (Exp. 11/2023), LA7703 (Exp. 11/2023), and LA9243 (Exp. 11/2023).

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 the manufacturer 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 additional information.

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: Orphenadrine Citrate Extended-Release Tablets (100 mg)by Sandoz

Variants: 100 mg, Extended-Release, Tablet

Lot Numbers:

JX6411 (Exp. 05/2022)

JX6413 (Exp. 05/2022)

KC0723 (Exp. 08/2022)

KC3303 (Exp. 08/2022)

KE4348 (Exp. 11/2022)

KE7169 (Exp. 11/2022)

KE4349 (Exp. 11/2022)

KL3199 (Exp. 03/2023)

KM0072 (Exp. 03/2023)

KS3939 (Exp. 03/2023)

LA7704 (Exp. 11/2023)

LA7703 (Exp. 11/2023)

LA9243 (Exp. 11/2023)

NDC:

0185-0022-01

Quantity: 7,908 bottles (790,800 tablets total)