🔍 Hydrochlorothiazide Recalls
Hydrochlorothiazide, a medication commonly used in hypertension treatment, recently underwent a significant recall. This article provides a detailed analysis of this recall, including its reasons, impact, and recommendations for affected patients.
Recall Details
Announcement and Reason: Aurobindo Pharma USA, Inc. initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg on October 24, 2022. This recall was due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril, which exceeds the proposed interim limit.
Product Description: The recalled product is Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, supplied in 90’s HDPE bottles. These are pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on the scored side and ‘19’ on the other.
Risks and Impacts
Cancer Risk: N-Nitroso-Quinapril, a nitrosamine impurity, can potentially increase cancer risk if people are exposed to it above acceptable levels over long periods. Nitrosamines are common in various foods and environments, but their presence in medication raises significant health concerns.
Patient Guidance: Patients using these medications are advised to consult their healthcare providers about continuing their current medication or considering alternative treatments.
Distribution and Communication
Distribution and Return: The affected batches, shipped nationwide since May 2021, are being recalled from the consumer level. Qualanex, on behalf of Aurobindo Pharma USA, Inc., is notifying distributors and customers to discontinue distribution of the recalled lots and return all recalled products.
Reporting and Support
Adverse Events Reporting: Patients experiencing any problems related to this medication are encouraged to report them to the FDA’s MedWatch Adverse Event Reporting program. This can be done online, by regular mail, or by fax.
Support Contact: Aurobindo Pharma USA, Inc. can be contacted for medical questions related to the recall at 1-888-504-2014 (live calls received 7:00 am to 4:00 pm M-F CST).
Additional Information
Other Recalls: Alongside Aurobindo Pharma USA, Lupin Pharmaceuticals also recalled four lots of quinapril for excessive nitrosamines in December 2022. This highlights a broader issue with nitrosamine impurities in various medications.
FDA Involvement: The recall is conducted with the knowledge and oversight of the U.S. Food and Drug Administration, ensuring regulatory compliance and public safety.
Conclusion
This recall underscores the importance of stringent quality checks in pharmaceutical manufacturing. Patients affected by this recall should seek immediate medical advice and report any adverse effects. Continuous monitoring and regulation by bodies like the FDA are crucial to safeguard public health.
Hydrochlorothiazide Recall Summary
| Aspect | Detail |
|---|---|
| Recall Date | October 24, 2022 |
| Company | Aurobindo Pharma USA, Inc. |
| Product | Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg |
| Reason | Presence of N-Nitroso-Quinapril |
| Risk | Potential increase in cancer risk |
| Patient Advice | Consult healthcare providers for alternative treatments |
| Reporting | FDA’s MedWatch Adverse Event Reporting program |
| FDA Involvement | Recall conducted with FDA knowledge |
| Contact for Queries | 1-888-504-2014 |
Key Takeaways
Patient Safety First: Consult healthcare providers immediately if you’re using the recalled medication.
Awareness and Reporting: Be aware of the recall details and report any adverse effects.
Regulatory Oversight: The recall is monitored by the FDA, ensuring compliance and public safety.
This article aims to provide comprehensive and insightful information about the Hydrochlorothiazide recall, distinguishing it from other generic content. For further details and updates, please refer to the FDA’s official website.
FAQs: Hydrochlorothiazide Recall
1. What is Hydrochlorothiazide and its primary use?
Hydrochlorothiazide is a diuretic medication often used to treat high blood pressure. By aiding the body in eliminating excess salt and water, it helps to manage blood pressure levels effectively.
2. What prompted the recall of Hydrochlorothiazide?
The recall was initiated due to the detection of N-Nitroso-Quinapril, a nitrosamine impurity, in amounts exceeding the interim acceptable limits. This impurity is associated with an increased risk of cancer if exposed over long periods.
3. How can I identify the recalled Hydrochlorothiazide product?
The recalled product is identifiable as pink colored, round, biconvex, film-coated tablets marked with ‘D’ on one side and ’19’ on the other. They were supplied in 90’s HDPE bottles.
4. Are there any reported health issues linked to this recall?
As of the latest information, there have been no reported adverse events directly associated with the recalled Hydrochlorothiazide. However, long-term exposure to the impurity found in these medications can potentially increase cancer risk.
5. What should I do if I have the recalled medication?
Patients possessing the recalled medication should consult their healthcare provider for advice on alternative treatments or adjustments to their medication regimen.
6. How are affected patients being notified about the recall?
Qualanex, representing Aurobindo Pharma USA, Inc., is contacting distributors and customers by phone and in writing, instructing them to halt distribution and return the recalled products.
7. What is the risk associated with Nitrosamine impurities?
Nitrosamines, commonly found in various foods and environmental sources, can increase cancer risk when present in high levels over prolonged periods. This makes their presence in pharmaceuticals a significant health concern.
8. Can I report any health issues related to the recalled product?
Yes, any health issues or adverse reactions experienced can be reported to the FDA’s MedWatch Adverse Event Reporting program, either online, by mail, or by fax.
9. What is the FDA’s role in this recall?
The U.S. Food and Drug Administration is overseeing the recall process, ensuring that it adheres to safety regulations and public health standards.
10. Are there alternatives to the recalled Hydrochlorothiazide medication?
Yes, alternative treatments are available. Patients may consider separate medications for each component of the combination drug or other antihypertensive agents, as advised by their healthcare provider.
11. How do I safely dispose of the recalled medication?
If you possess the recalled medication, do not dispose of it in your regular trash or flush it down the toilet. Contact Aurobindo Pharma USA or your local pharmacy for guidance on proper disposal methods that adhere to environmental safety standards.
12. Are there any immediate health risks if I continue taking the recalled medication?
While there have been no immediate adverse events reported, continued use of the recalled medication could potentially increase long-term cancer risk due to nitrosamine impurity. Consult with your healthcare provider for a safer alternative.
13. How long have the affected lots been in circulation?
The affected lots of Hydrochlorothiazide began distribution in May 2021. This extended period in circulation highlights the importance of promptly checking medication lots against recall notices.
14. Is this recall isolated to the United States?
Yes, this recall by Aurobindo Pharma USA, Inc. is specific to the United States market. Patients outside the U.S. should consult local health authorities or their healthcare providers for information relevant to their region.
15. What measures are being taken to prevent future occurrences?
Pharmaceutical companies are expected to implement stricter quality control measures and enhanced testing for impurities like nitrosamines to prevent similar issues in the future. Regulatory bodies like the FDA are also likely to intensify scrutiny and guidelines to ensure public safety.