The recalls were made because the medications failed sterility testing.
Nephron Pharmaceuticals is voluntary recalling around 2.1 million doses of epinephrine injections and other medications due to lack of assurance of sterility.
The recall on FDA’s website includes multiple lots of oxytocin, sodium bicarbonate, calcium gluconate, lidocaine HCl, glycopyrrolate, and several other injections.
“Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots. We do not take this lightly,” Nephron CEO Lou Kennedy said in a statement emailed to Formulary Watch.
“While there has been no impact to patient safety, and there is no evidence of contamination, Nephron has decided in the interest of patients to proceed with this recall process. The company is prepared to provide the resources and information necessary to healthcare providers and patients to make certain they have anything they need and any questions answered.”
The products were manufactured at Nephron’s facility in Columbia, S.C.
Its 503B compounding operation is open, but there have been ongoing updates to processes around the facility, which may result in changes or pauses to production schedules or outbound packaging in 503B, Nephron said.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More