Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

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Amneal Pharmaceuticals announced on March 27, 2024 that it was voluntarily recalling four lots of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes. The recall was issued because some bottles may have been overfilled, resulting in over potency. Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is used to treat enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The company stated in a press release that the error occurred during the manual filling of the bottles at the manufacturing stage. The recommended maximum daily dose allowance is 2 gm per day. If patients were prescribed 500 mg/10 mL, the maximum dosage would be exceeded, which could be harmful to patients with renal insufficiency, according to the company.

“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,” the company states in the press release.

The recalled lots were distributed nationwide in the United States to wholesalers and distributors between Nov. 9, 2023 and Feb. 20, 2024. Lot information is as follows:

• NDC No. 69238-2261-3; Lot 22613003A; Expiration Date 09/2025; Pack size 80 mL
• NDC No. 69238-2261-7; Lot 22613004A; Expiration Date 09/2025; Pack size 150 mL
• NDC No. 69238-2261-7; Lot 22613005A; Expiration Date 09/2025; Pack size 150 mL
• NDC No. 69238-2261-5; Lot 22613005B; Expiration Date 09/2025; Pack size 300 mL.

The company is advising retailers to examine inventory and cease dispensing recalled lots. Amneal states it has not received any confirmed reports of adverse events related to the recall. Adverse events may be reported to FDA via its MedWatch program.

In other company news, FDA approved Amneal’s abbreviated new drug application for ciprofloxacin and dexamethasone otic suspension on March 25, 2024 (1). Ciprofloxacin and dexamethasone otic suspension combines a fluoroquinolone antibacterial, ciprofloxacin, and a corticosteroid, dexamethasone. It is used to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis externa children age six months and older, adults, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa.

“This approval represents the addition of another complex, high value medicine,” said Andy Boyer, executive vice president, chief commercial officer–Generics, in a press release. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”

Amneal is headquartered in Bridgewater, NJ, and develops, manufactures, and distributes more than 270 pharmaceutical products, mostly within the United States. The company produces generic drugs across a variety of therapeutic areas, including injectables and biosimilars, as well as specialty branded pharmaceuticals for central nervous system and endocrine disorders.

Reference

1. Amneal Pharmaceuticals. Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension. Press Release. March 25, 2024.

Source: FDA