News & Press: Patient Safety

Recall Alert: PharMEDium Expands Nationwide Recall of Additional Lots of Compounded Sterile Products

Thursday, January 11, 2018  
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SIS Patient Safety Alert 01/11/2018: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDAissues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility.  Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.  To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.

 

BACKGROUND: The recall is being expanded because PharMEDium conducted an extensive review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results following the most recent inspection. The original recall included a total of 55 lots of different products impacting 25,327 units. The expanded recall includes all lots within expiry compounded at the Memphis, TN facility. Finished product release testing for both sterility and endotoxin were acceptable for all lots. Although there were no defects identified in these products, as a conservative measure, this recall is being expanded.

The products can be identified by referring to the sample labels provided. These products were distributed nationwide in the USA to hospitals/clinics. A complete list of all recalled products can be found on pharmedium.com.

 

RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website for more information on the specific lot numbers affected and contact information: www.pharmedium.com

 

Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at 1-800-523-7748, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at recall17023@pharmedium.com.

 

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

  • Complete and submit the report Onlinefda.gov/medwatch/report
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

 

  • Service code 2K5856, 10 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag 
  • Service code 2K7710, 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 
  • Service code 2K8120, 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8124, 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8179, 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride
  • Service code 2K8191, 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride
  • Service code 2K8204, 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium
  • Service code 2K8241, 3 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8292, 1 mg/mL Midazolam HCl ( Preservative Free) in 0.9% Sodium Chloride Injection USP 
  • Service code 2K8453, 5 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8468, 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8490, 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium 
  • Service code 2K8498, 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8638, 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8643, 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • 16. Service code 2K8667, 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8669, 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 268869, 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8880, 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • 20. Service code 2K8889, 2 mcg/mL Fentanyl Citrate and 0.15% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K8937, 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2K9037, 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 
  • Service code 2K9100, 0.5 mg/mL Midazolam HCl in 0.9% Sodium Chloride 
  • Service code 2K9115, 4 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2M8510, 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 
  • Service code 2P6165, 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 
  • Service code 2P6179, 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2P8652, 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 
  • Service code 2R3303-5, 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 
  • Service code 2R3306-K5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 
  • Service code 2R333-5, 50 mg/mL EPHEDrine Sulfate Injection (Preservative Free) 
  • Service code 2R3334-5, 0.5% Ropivacaine HCl Injection (Preservative Free) 
  • Service code 2R3417-K5, 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 
  • Service code 2T6165, 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 
  • Service code 2T6178, 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 
  • Service code 2T6231, 3 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe 
  • Service code 2T6270,1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 
  • Service code 2T6401, 2 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 
  • Service code 2T6455, 2 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 
  • Service code 2T6656, 5 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 
  • Service code 2T6663, 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium 
  • Service code 2T6827, 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 5% Dextrose 
  • Service code 2T8474, 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 
  • Service code 3117NO, 5 mg/mL Labetalol HCI 
  • Service code 3217NO-K25, 0.2 mg/mL Glycopyrrolate 3 mL in 3 mL BD Syringe Kit Check Tagged 
  • Service code 3303NO, 50 mcg/mL Fentanyl Citrate Injection 
  • Service code 3357N0-K25, 20 mg/mL Succinylcholine Chloride Injection 

Read the FDA MedWatch Safety Alert, including a link to the press release and product photos.

 

Source: U.S. Food and Drug Administration (FDA) Accessed: 01/11/2018



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