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  4. PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Lack of Sterility
Company Name:
PharMEDium Services, LLC
Brand Name:
Brand Name(s)
PharMEDium Services, LLC
Product Description:
Product Description
Compounded injectables

Company Announcement

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of 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.

The recall is being issued because PharMEDium conducted a retrospective 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 control program during recent inspection to provide verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results.  The review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills.  The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip.  Finished product release testing for both sterility and endotoxin were acceptable.  Although there were no defects identified in these products, as a conservative measure, a recall is being initiated.  .

The products can be identified by referring to the sample labels provided. These products were distributed nationwide in the USA to hospitals/clinics.

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 (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at dantonio@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 Online
  • Regular Mail or Fax: Download form 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

Product Description

Lot Number
2K8880 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790045M
2K8468 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790055M
2K8889 2 mcg/mL Fentanyl Citrate and 0.15% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790091M
2P8652 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 172790111M
2P6179 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 172790115M
2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 172790156M
2K8124 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172820087M
3357NO-K25 20 mg/mL Succinylcholine Chloride Injection (Preserved) Kit Check Tagged 172820144M
2K8490 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910035M
2K8191 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910106M
3217NO-K25 0.2 mg/mL Glycopyrrolate 3 mL in 3 mL BD Syringe Kit Check Tagged 172910127M
2R3303-5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 172910135M
2K8453 5 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910154M
2P6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 172930052M
2K9115 4 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 172930100M
2K8204 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172970053M
3303NO-K25 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged 172970130M
2T6663 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 172970158M
2R3303-5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 172980111M
2K9037 1 mg/mL Midazolam HCl ( Preservative Free) in 0.9% Sodium Chloride Injection USP 172980202M
2K8498 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 173020065M
2K9100 0.5 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173020131M
2T6231 3 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe 173020134M
2K8638 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173020141M
2K8241 3 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173020185M
2R3306-K5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged 173020228M
2R3333-5 50 mg/mL Ephedrine Sulfate Injection (Preservative Free) 173020233M
2T6455 2 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 173030008M
2P8652 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 173030017M
3303NO 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173030024M
2K8869 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173030050M
2K8643 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173030080M
2K7710 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173030114M
2T6827 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 5% Dextrose 173030146M
2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040042M
2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040043M
2K8292 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173040069M
2T6270 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173040072M
2M8510 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040078M
2K8120 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173040265M
2T6656 5 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 173040283M
2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173110038M
2K8468 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173110066M
2K8667 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 173110079M
2T6178 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173110142M
2K5856 10 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag 173110193M
2T8474 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173170055M
3117NO 5 mg/mL Labetalol HCI 173170127M
2K8179 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173200084M
2R3417-K5 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173200212M
2K8669 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 173210054M
2K8937 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173210060M
3303NO 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173210085M
2T6401 2 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173210101M
2R3334-5 0.5% Ropivacaine HCl Injection (Preservative Free) 173210124M

Expanded Press Release   

Company Contact Information

Consumers:
Denis Antonio, Quality Manager, Clinical Pharmacist
(847) 457-2733
dantonio@pharmedium.com
Media:
Sanjeev Bahl, Vice President of Quality
(847) 457-2256
sbahl@pharmedium.com

Product Photos

  • "10 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag"
  • " Image 1 - 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride"
  • "0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 1 - 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride"
  • "0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium"
  • "3 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "1 mg/mL Midazolam HCl ( Preservative Free) in 0.9% Sodium Chloride Injection USP"
  • "5 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 1 - 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium"
  • "Image 1 - 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride"
  • "4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 1 - 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 2 - 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride"
  • "2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 2 - 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "2 mcg/mL Fentanyl Citrate and 0.15% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 1 - 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride"
  • "0.5 mg/mL Midazolam HCl in 0.9% Sodium Chloride"
  • "4 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride"
  • " Image 2 - 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride"
  • " Image 3 - 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride"
  • "Image 2 - 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride"
  • "Image 1 - 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride"
  • "Image 1 - 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection"
  • "Image 2 - 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection"
  • "0.5% Ropivacaine HCl Injection (Preservative Free)"
  • "Image 2 - 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride"
  • " Image 4 - 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride"
  • "Image 2 - 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride"
  • "3 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe"
  • "Image 2 - 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride"
  • "2 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride"
  • "2 mg/mL Morphine Sulfate in 0.9% Sodium Chloride"
  • "5 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride"
  • "10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium"
  • "1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 5% Dextrose"
  • "Image 3 - 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection"
  • "5 mg/mL Labetalol HCI"
  • "0.2 mg/mL Glycopyrrolate 3 mL in 3 mL BD Syringe Kit Check Tagged"
  • "50 mcg/mL Fentanyl Citrate Injection"
  • "20 mg/mL Succinylcholine Chloride Injection"
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