Three lots of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents used in the emer­gency med­i­cine ep­i­neph­rine are be­ing vol­un­tar­i­ly re­called by the man­u­fac­tur­er.

Spec­trum Lab­o­ra­to­ry Prod­ucts sent out a world­wide vol­un­tary re­call for the lots of ep­i­neph­rine USP, a bulk API pow­der used to man­u­fac­ture the pre­scrip­tion prod­uct. Ac­cord­ing to the FDA no­tice, the main com­plaints have found the prod­uct to be “dis­col­ored.”

Ep­i­neph­rine is pri­mar­i­ly used in life-threat­en­ing con­di­tions and treats a va­ri­ety of con­di­tions, in­clud­ing asth­ma, hy­per­sen­si­tiv­i­ty re­ac­tions, heart fail­ure, hy­per­ten­sion or shock, among oth­ers. Ac­cord­ing to the FDA, if the fin­ished prod­uct is man­u­fac­tured with dis­col­ored ma­te­r­i­al, it could re­sult in a less-ef­fec­tive prod­uct and may re­sult in death.

The pow­der it­self is pack­aged in “am­ber glass bot­tles” and is in a vac­u­um-sealed pouch. The af­fect­ed prod­uct can be iden­ti­fied by Spec­trum’s cat­a­log num­ber EP130 and was dis­trib­uted from its fa­cil­i­ties to cus­tomers in the US and Cana­da. The af­fect­ed lot num­bers are 1KG0865, 2KL0353 and 2KF0151.

In a state­ment emailed to End­points News, Tej Parikh, Spec­trum’s com­pli­ance man­ag­er, said that dis­col­oration may oc­cur when ex­posed to oxy­gen, but this does not nec­es­sar­i­ly mean that po­ten­cy is im­pact­ed.

“In this sit­u­a­tion, dis­col­oration was lim­it­ed to three lots of our Ep­i­neph­rine (L-Adren­a­line) USP prod­uct line. As a mat­ter of pre­cau­tion, Spec­trum Lab­o­ra­to­ry Prod­ucts has proac­tive­ly de­cid­ed to vol­un­tar­i­ly re­call these three lots. No oth­er lots of our Ep­i­neph­rine USP prod­uct line are af­fect­ed and we have not re­ceived any re­ports of ad­verse events re­lat­ed to this re­call,” Parikh said.

The FDA al­so not­ed that Spec­trum is no­ti­fy­ing dis­trib­u­tors and cus­tomers and is mak­ing the nec­es­sary arrange­ments for the re­turn of re­called prod­ucts. Con­sumers, phar­ma­cies and dis­trib­u­tors that have the cat­a­log num­ber EP130 should stop its use im­me­di­ate­ly.

An­oth­er one of the more re­cent re­calls oc­curred when Au­robindo Phar­ma USA is­sued a vol­un­tary re­call of two batch­es of the heart med­ica­tion Quinapril. That re­call was is­sued over a “ni­trosamine drug sub­stance-re­lat­ed im­pu­ri­ty” above the pro­posed lim­it.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.