Amneal Pharmaceuticals is recalling four lots of an antibacterial after a manufacturing error may have resulted in overfilled bottles.
The recall covers four different packaging formats of the company’s generic vancomycin hydrochloride for oral solution, which treats intestine inflammation (or enterocolitis) caused by bacteria, plus colon inflammation (pseudomembranous colitis) caused by antibiotic-related C. difficile infection.
Some bottles “may have been overfilled” during the manual bottle-filling stage of manufacturing, the FDA noted in its recall announcement.
Overfilled bottles may lead to dosing that exceeds the recommended maximum daily allowance, the agency said. That limit is set at up to 2 mg per day, but the bottling mistake could cause patients to receive double that dose.
Taking too much vancomycin can lead to worsening renal function, which in turn could cause electrolyte concerns such as high potassium, a risk factor for cardiac arrest.
So far, the company has not received any reports of adverse events linked to the recall, the FDA said.
The impacted lots contained pack sizes of 80 mL, 300 mL and two batches at 150 mL. The lots all expire in September 2025.
Amneal is alerting customers of the recall via mail and is arranging for a return of the products. Retailers, customers and consumers are instructed to check to see whether they possess any affected bottles.
Meanwhile, other recent recalls across the industry include Sun Pharma’s withdrawal of 5,000 bottles of febuxostat tablets due to a report of microbial contamination at the company’s manufacturing facility.
Pfizer last January recalled a batch of its vancomycin hydrochloride, although in injection vial form, due to the possible presence of glass particles in the vials.