Zydus Pharmaceuticals (USA) Inc. Recalls Acyclovir Sodium Injection, 50 mg/mL

News
Article

The company is recalling the product because of crystallization in vials.

Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ) announced on March 24, 2021 that it was voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, in 10 mL and 20 mL vials. The recall is a result of complaints of crystallization in vials. According to the company, administration of crystallized product could result in life-threatening adverse reactions, such as obstruction of blood vessels and blood clots.

The recalled product is packaged in single-dose glass vials. Specific information on the recalled lots can be found on FDA’s website. It was distributed nationwide in the United States to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company LLC. As of the date of the company announcement, the company has not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.

Acyclovir Sodium Injection, 50 mg/mL is used to treat herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection, and varicella-zoster (shingles) infections in immunocompromised patients, according to the company.

Source: FDA

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes