Compounded Heparin Sodium Recalled

News
Article

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

SCA Pharmaceuticals (Windsor, CT) announced on August 18, 2020 that it is voluntarily recalling 10 lots of heparin sodium because the product contains undeclared benzyl alcohol, a preservative. Methylparaben and propylparaben, which are not contained in the product, were listed on the label as preservatives. The labeling problem was identified when the company was investigating a low potency test result.

Heparin Sodium is used as an anticoagulant, and the company stated in a press release that “serious adverse reactions including fatal reactions and ‘gasping syndrome’ are likely to occur in premature neonates and low-birth weight infants in the neonatal intensive care unit who receive benzyl alcohol as a preservative in infusion solutions, in any amount.” Because of these and other possible adverse reactions, the company stated that preservative-free heparin sodium injections are recommended for pregnant patients and “Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women.”

As of the time of the press release, the company has not received any reports of adverse events. Information on the recalled lots can be found on FDA.gov and adverse events may be reported to FDA’s MedWatch program.

Source: FDA

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
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
Related Content