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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Rifampin Capsules Recalled Due to Low Potency and Impurities

Agency Publication Date: January 30, 2024
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Summary

Lupin Pharmaceuticals Inc. has recalled 32,136 bottles of Rifampin Capsules USP (150mg and 300mg), a prescription antibiotic used to treat tuberculosis and other bacterial infections. The medication is being recalled because it may be subpotent and failed testing for impurities and degradation. The recall affects 30-count bottles distributed to 32 wholesale accounts and 156 distribution sites. No incidents or injuries have been reported to date.

Risk

Subpotent medication may fail to effectively treat the underlying bacterial infection, which could lead to treatment failure or the development of drug-resistant bacteria. Additionally, failed impurity testing indicates the presence of unintended substances that could pose health risks to patients.

What You Should Do

  1. This recall affects Rifampin Capsules USP (150mg and 300mg) sold in 30-count bottles under the Lupin Pharmaceuticals Inc. label, manufactured for Lupin Pharmaceuticals in Baltimore, Maryland.
  2. Identify your medication by checking the National Drug Code (NDC) and lot numbers on the bottle. The 150mg capsules have NDC 68180-658-06 and lot numbers A200816 (exp 1/2024) or A201248 (exp 3/2024). The 300mg capsules have NDC 68180-659-06 and lot number A200817 (exp 1/2024).
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (150mg)
Variants: 150mg, 30-count bottle, Rx Only
Lot Numbers:
A200816 (exp 1/2024)
A201248 (exp 3/2024)
NDC:
68180-658-06

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland; Manufactured by: Lupin Limited, India.

Product: Rifampin Capsules USP (300mg)
Variants: 300mg, 30-count bottle, Rx Only
Lot Numbers:
A200817 (exp 1/2024)
NDC:
68180-659-06

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland; Manufactured by: Lupin Limited, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93753
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Wholesale accounts; Distributors
Manufactured In: United States, India
Units Affected: 2 products (15,576 Bottles; 165,60 bottles)
Distributed To: Nationwide
Agency Last Updated: April 3, 2024

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 ยท 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.