Amneal Recalls Vancomycin Hydrochloride Oral Solution

Some bottles may be super potent

Attention Patients, Health Professionals, and Pharmacies:

Amneal Pharmaceuticals issued a safety notice on March 27 for a recall of specific lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL. This recall has been necessitated due to the potential overfilling of some bottles, resulting in a super potent dosing regimen which could pose serious health risks.

Recalled Product Concerns

The recall affects four lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL, packaged in 80 mL, 150 mL, or 300 mL sizes. The overfilled bottles may lead to patients inadvertently receiving up to four grams of oral vancomycin per day, exceeding the recommended maximum daily dose. This overdose could be harmful, particularly for patients with renal insufficiency or those with inflammatory disorders of the intestinal mucosa.

Potential risks

Patients receiving excess doses of vancomycin may experience adverse reactions, including worsening renal function and electrolyte abnormalities such as high potassium levels, which could lead to cardiac arrest. The error occurred during the manual bottle filling stage of manufacturing.

What You Should Do

Check Your Product: Patients and healthcare providers should examine the bottle of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL, and discontinue use if the lot number matches the recalled lots.

Contact Amneal: Reach out to Amneal Pharmaceuticals via telephone or email for recall information and instructions on returning the product. Amneal can be contacted at 1-833-582-0812 or via email at Vancomycin_Recall@amneal.com.

Report Adverse Events: If you’ve experienced any problems or adverse reactions related to this product, it’s crucial to contact your physician or healthcare provider immediately. You can also report adverse reactions or quality problems to Amneal Drug Safety by phone at 1-877-835-5472 or via email at DrugSafety@amneal.com.

Healthcare Professionals: Pharmacists and healthcare professionals are urged to check their inventory for the impacted lots and cease dispensing immediately. Contact Amneal directly for further instructions.

FDA Reporting

Both patients and healthcare professionals are encouraged to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Conclusion

Patient safety is of utmost importance, and swift action is necessary to mitigate any potential risks associated with this recall. By following the outlined recommendations and reaching out to Amneal Pharmaceuticals for guidance, we can ensure the well-being of those affected by this recall. Stay informed, stay safe.

See recall notice and Amneal Pharmaceuticals contact information.