FDA MedWatch – Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL by Amneal Pharmaceuticals

TOPIC: Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL by Amneal Pharmaceuticals: Recall – Due to the Potential for Some Bottles to Be Super Potent Which May Be Harmful

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Amneal Pharmaceuticals is recalling 4 lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, because some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2 gm/day and patients prescribed a dosing regimen of 500 mg/ 10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for Oral Solution, USP 250 mg/ 5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

RECOMMENDATIONS: 

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Patients who have Vancomycin Hydrochloride for Oral Solution USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions.

• If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472 or via e-mail at DrugSafety@amneal.com.

• Patients may call Amneal at 1-833-582-0812 or email Vancomycin_Recall@amneal.com for further information and instructions for the product return.

• Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email at Vancomycin_Recall@amneal.com for further information.

• Retailers who have Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots and contact Amneal directly via email at Vancomycin_Recall@amneal.com or by telephone 1-833-582-0812.

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

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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