FDA Notification: Hikma Pharmaceuticals USA Inc. Expands Voluntary Nationwide Recall of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags, One Lot

**FDA Notification: Hikma Pharmaceuticals USA Inc. Expands Voluntary Nationwide Recall of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags, One Lot**

In a recent development, Hikma Pharmaceuticals USA Inc. has announced an expansion of its voluntary nationwide recall of Acetaminophen Injection, 1000mg/100mL (10mg/mL) bags. This recall pertains specifically to one lot of the product, and it has been initiated in collaboration with the U.S. Food and Drug Administration (FDA). The recall is a precautionary measure aimed at ensuring patient safety and maintaining the highest standards of pharmaceutical quality.

### Background on Acetaminophen Injection

Acetaminophen, commonly known by its brand name Tylenol, is a widely used analgesic and antipyretic medication. It is often prescribed to manage mild to moderate pain and to reduce fever. The injectable form of acetaminophen is typically used in hospital settings for patients who are unable to take oral medications or require rapid pain relief.

### Reason for the Recall

The recall has been initiated due to the potential presence of particulate matter in the affected lot. Particulate matter in injectable medications can pose serious health risks, including local irritation, allergic reactions, and even more severe complications such as embolism, which can be life-threatening. The presence of such contaminants is a significant concern, particularly for vulnerable populations such as the elderly, pediatric patients, and those with compromised immune systems.

### Details of the Affected Lot

The specific lot under recall is identified as follows:

– **Product Name:** Acetaminophen Injection, 1000mg/100mL (10mg/mL) bags
– **NDC Number:** [Insert NDC Number]
– **Lot Number:** [Insert Lot Number]
– **Expiration Date:** [Insert Expiration Date]

Healthcare providers, pharmacies, and distributors are urged to check their inventories and immediately cease the distribution and use of the affected lot. Patients who have received the recalled product should be monitored for any adverse reactions and seek medical attention if they experience any unusual symptoms.

### Actions Taken by Hikma Pharmaceuticals

Hikma Pharmaceuticals has taken swift action to address the issue. The company has notified its distributors and customers through written communication and is arranging for the return of all recalled products. Additionally, Hikma is conducting a thorough investigation to determine the root cause of the contamination and to implement corrective measures to prevent future occurrences.

### Recommendations for Healthcare Providers and Patients

Healthcare providers are advised to:

1. **Stop Using the Recalled Product:** Immediately discontinue the use of the affected lot and quarantine any remaining stock.
2. **Report Adverse Events:** Report any adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting program.
3. **Inform Patients:** Notify patients who may have received the recalled product and advise them to seek medical attention if they experience any adverse symptoms.

Patients who have concerns about the recall should:

1. **Contact Their Healthcare Provider:** Discuss any potential risks and symptoms with their healthcare provider.
2. **Monitor for Symptoms:** Be vigilant for any signs of adverse reactions, such as swelling, redness, pain at the injection site, or systemic symptoms like fever and chills.
3. **Report Issues:** Report any adverse reactions to the FDA’s MedWatch program.

### Conclusion

The expanded recall of Acetaminophen Injection by Hikma Pharmaceuticals underscores the importance of vigilance and quality control in the pharmaceutical industry. While the recall may cause temporary inconvenience, it is a necessary step to ensure patient safety and maintain trust in healthcare products. Both healthcare providers and patients are encouraged to stay informed and take appropriate actions to mitigate any potential risks associated with the recalled product.

For more information, healthcare providers and patients can visit the FDA’s website or contact Hikma Pharmaceuticals directly. The FDA and Hikma Pharmaceuticals remain committed to safeguarding public health and will continue to provide updates as more information becomes available.

• Source Link: https://platohealth.ai/fda-alert-hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-of-one-lot-of-acetaminophen-injection-1000mg-100ml-10mg-ml-bags/