Vancomycin recall issued due to potency issue

Vancomycin recall overview: 

• Who: Anmeal Pharmaceuticals recalled four lots of its vancomycin hydrochloride for oral solution. 
• Why: Bottles of the vancomycin hydrochloride were overfilled, leading to patients receiving a larger dose than prescribed.
• Where: The vancomycin recall is effective across the United States.

Amneal Pharmaceuticals issued a vancomycin recall for four lots of its vancomycin hydrochloride for oral solution because the bottles were overfilled.

The vancomycin potency can lead to a higher dose than prescribed for patients. The issue occurred during the manual bottle filling stage.

The vancomycin orał recall includes lots 22613003A, 22613004A, 22613005A and 22613005B of the vancomycin solution with an expiration date of 09/2025 in 80 milliliter, 150 mL and 300 ml bottles. The lots were distributed between Nov. 9, 2023, and Feb. 20, 2024.

The highest recommended daily dose of the vancomycin oral solution is 2 grams per day, so patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency according to the recall.

Renal issues can lead to electrolyte abnormalities such as high potassium leading to cardiac arrest, the vancomycin recall says.

No reports of adverse effects from vancomycin recall, company says

Anmeal Pharmaceuticals says it has not received any reports of illness directly related to the recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Customers and retailers can contact Amneal by phone at 833-582-0812 between 8 a.m. and 5 p.m. ET, Monday through Friday, or by email at Vancomycin_Recall@amneal.com.

The FDA published two voluntary nationwide recalls in December 2022 for vancomycin and daptomycin injection products offered by Hospira Inc. and Accord Healthcare, respectively. 

Are you affected by the vancomycin recall? Let us know in the comments. 

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