An East-West recall imbroglio is afoot as a pair of drugmakers on opposite ends of the country launch market pulls on contamination and labeling concerns. For one—the Aurobindo subsidiary now dubbed Eugia US—this isn’t its first product purge this year, either.
New Jersey’s Eugia, formerly known as AuroMedics Pharma, is yanking a single lot of acyclovir sodium injection single-dose vials in the U.S. after receiving a product complaint over “dark red, brown and black particulate inside the vial.”
Heading west, California’s Golden State Medical Supply is recalling one lot apiece of 75-mg clopidogrel tablets and 25-mg atenolol tablets, which the company ascribed to a labeling mix-up.
Neither company has received any side effect or safety flags tied to the suspect products, the companies reported separately in notices on the FDA’s website earlier this week.
Eugia’s acyclovir sodium injection is used to treat initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. The drug is also used to treat first clinical episodes of genital herpes in non-immunocompromised patients.
Giving a patient an intravenous drug tainted with particulates could cause inflammation, allergic reactions or circulatory system complications that “could be life threatening,” Eugia warned in its recall notice.
The lot in question was set to expire next August, the company added, noting that it shipped the entirety of the batch to wholesalers across the country in early June of this year.
Golden State Medical Supply, for its part, launched its twin tablet recall after getting hit with a complaint that a bottle of clopidogrel—used to lower the risk of stroke, blood clots or serious heart problems in patients who’ve had heart attack or other cardiovascular issues—was mislabeled as the hypertension med atenolol.
The product pull covers one lot of 1,000-count bottles of clopidogrel and a solo batch of atenolol—also in 1,000-count bottles—both of which were set to expire in December 2023.
Particulate and labeling snafus aren’t uncommon in the pharma realm. Meanwhile, this is Eugia’s second brush with contamination since late January.
That month, the company, still operating under the AuroMedics moniker, issued a voluntary recall of the antibiotic polymyxin B after a complaint that a hair was found in a vial.
That voluntary recall came just days after the drugmaker's parent company, Aurobindo, received an FDA warning letter for failing to adequately investigate batch failures of pharmaceutical ingredients and not evaluating the possible effect of changes on the intermediates and APIs manufactured at its facility in Hyderabad, India.