Recall report: Zydus recalls herpes drug after crystallization complaints; Alembic pulls low blood pressure drug for incorrect labeling
It’s been a relatively quiet start to the year in terms of drug recalls, but the FDA hit two generics makers late last week for manufacturing issues.
First, Zydus Pharmaceuticals recalled a herpes and shingles drug Thursday after complaints of crystallization in vials.
The administration of crystallized acyclovir sodium injection could cause inflammation of the vein or blood clots, an increase in stroke and heart attack and decreased liver or kidney function, according to the FDA. Zydus hasn’t received any reports of negative reactions connected to the crystallization.
The drug is packaged in single-dose glass vials, and distributed across the US by Cardinal Health, AmerisourceBergen Drug Corporation and Morris & Dickson Company. The recall includes four lot numbers: L000155, L000156, L000126 and L000127. Two of those lots are 20-mL vials and the other two are 10-mL vials. Three of the lots were set to expire in December 2021, and one in January 2022.
Zydus has notified distributors and customers by email, and FedEx overnight courier service has arranged for the return of all the retailed products.
In 2019, an FDA inspector issued a warning letter to the drugmaker after manufacturing issues were uncovered at its Moraiya, India plant.
India-based Alembic Pharmaceuticals also recalled one lot of its telmisartin tablets due to incorrect labeling. A market complaint said that in at least one instance, the low blood-pressure drug was labeled as a 30-count of 20-milligram tablets, but actually contained a 30 count of 40-milligram strength..
That puts consumers of the drug at risk for low blood pressure, kidney damage or life-threatening elevation of potassium, the FDA said. The affected lot is number 1905005661 and expires in March 2022.
The telmisartin tablets are the third drug to be recalled this year due to mislabeling. In January, Meitheal Pharmaceuticals recalled a lot of cisatracurium besylate injection after a report that a portion was mislabeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL. Earlier this month, Bryant Ranch Prepack recalled four lots — 47 bottles — of the blood pressure drug spironolactone after a report that bottles labeled as 50-milligram contained tablets that were actually 25-milligram, and bottles labeled as 25-milligram contained 50-milligram tablets.
Two male enhancement supplements were also recalled last week. PremierZen and Imperial were found to have undeclared sildenafil and tadalafil, which could lower blood pressure to dangerous levels.
On December 17, the FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.
