Manufacturer recalls several compounded drugs over sterility issues

September 17, 2019
Christine Blank
Christine Blank

Fentanyl citrate and ephedrine sulfate are among the medications affected.

Compounded fentanyl citrate, oxytocin, and ephedrine sulfate are among the drugs being recalled nationwide due to sterility issues.

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs to the consumer level due to lack of assurance of sterility, the company said in a press release on FDA’s website.

"Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening,” the pharma maker said. However, KRS has not received any reports of adverse events related to the recall.

The products were distributed nationwide to hospitals, doctor’s offices, surgical centers, pharmacies, veterinarians and patients.

Related:Compounding facilities face new FDA regs

Among the numerous treatments recalled are oxytocin 30 units (Preservative Free) in 0.9% Sodium Chloride 500 mL IV Bag, compounded; ephedrine sulfate in 0.9% Sod Chl 25 mg/5mL (5 mg/mL) (PF) 5 mL fill in a 6 mL Sing Dose Syr, compounded; and Ketamine HCl 50 mg/5mL (10 mg/mL) (1%)(PF) in 0.9% Sod. Cl. 5 mL fill in a 6 mL Single Dose Syr, compounded.

Healthcare providers with the recalled products should stop using them and return to KRS. Consumers who have recalled should stop using them and contact their doctor or healthcare provider, KRS said.

KRS is arranging for credit of all recalled products. Call KRS at 888-398-9950 or email recall@krsbio.com.

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In a separate recall, Darmerica LLC is voluntarily recalling 2 lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level due to a label mix-up. “Product intended for further compounding use by pharmacies labeled as Quinacrine API was tested and identified as Artemisinin API. Artemisinin and its semisynthetic derivatives are a group of drugs used against malaria,” said the manufacturer in a press release on FDA’s website.

Quinacrine Dihydrochloride was distributed nationwide to 14 compounding pharmacies.

Receiving artemisinin rather than quinacrine could lead to deterioration of disease that is being treated, serious adverse reactions which would need medical or surgical intervention, as well as mistaken evaluation and remediation of adverse reactions.

However, Darmerica LLC has not received any reports of adverse events related to the recall.

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