10 drug, device recalls in July

Here are 10 drug and medical device recalls that the FDA reported in July:

1. Mylan Pharmaceuticals recalled one batch of Insulin Glargine Injection Pens because they were incorrectly labeled.

2. Getinge USA Sales recalled 64 anesthesia systems after 21 complaints about cracked switches on the system's suction unit were filed. The issue could delay a procedure, block air ventilation and result in choking, brain injury because of lack of oxygen, and death.

3. Hospira, a Pfizer company, recalled one lot of its Propofol Injectable Emulsion vials because a visible particulate was found in an annual test. Potential effects include blood vessel blockage, heart attack and tissue necrosis, but there have been no adverse reports submitted.

4. American Contract Systems recalled 99,900 COVID-19 test kits and 61,500 Clean Catch Urine Kits after the FDA said the company's factory had untrained employees. 

5. Vi-Jon extended its initial June 22 recall to include all lots of CVS Health's Magnesium Citrate Saline Laxative Oral Solution. The recall follows a microbial contamination, which could have "serious, life threatening" results for immunocompromised people. One adverse reaction has been reported. 

6. MKS Enterprise recalled its honey product, Dose Vital, after an FDA analysis found an ingredient used to treat erectile dysfunction but isn't approved for the product. The ingredient, tadalafil, has also made its way into other "male sexual enhancement" drugs and has prompted other companies to recall their products. The FDA has reported zero adverse reactions. 

7. Smiths Medical recalled 118,055 syringe infusion pumps after reports of one death and seven serious injuries. The software malfunctions are tied to false alarms that could result in under- or over-infusion.

8. Ultra Supplement recalled one lot of Sustango because of the presence of tadalafil. The health risks could be life-threatening, but no complaints have been filed. 

9. Baxter recalled nine Abacus Order Entry and Calculation Software applications, which affects 1,114 customers. The recall is because of "a risk that final printed bag labels for compounded mixtures may contain incorrect information," according to the FDA. There have been five complaints, zero injuries and zero deaths associated with the recall. 

10. Covidien recalled more than a million Palindrome and Mahurkar hemodialysis catheters because of a hub defect. One complaint has been filed.

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