Safety

Company Announcement

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.

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

For Immediate Release

December 27, 2017

Contact

Consumers

Denis Antonio, Quality Manager, Clinical Pharmacist
dantonio@pharmedium.com
(847) 457-2733

Media

Sanjeev Bahl, Vice President of Quality
sbahl@pharmedium.com
(847) 457-2256

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.

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

 

Service CodeProduct DescriptionLot Number
2K88802 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172790045M
2K84682 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172790055M
2K88892 mcg/mL Fentanyl Citrate and 0.15% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172790091M
2P86521 mg/mL Morphine Sulfate in 0.9% Sodium Chloride172790111M
2P61791 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride172790115M
2T61651 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride172790156M
2K81242 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172820087M
3357NO-K2520 mg/mL Succinylcholine Chloride Injection (Preserved) Kit Check Tagged172820144M
2K84902 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172910035M
2K81910.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172910106M
3217NO-K250.2 mg/mL Glycopyrrolate 3 mL in 3 mL BD Syringe Kit Check Tagged172910127M
2R3303-550 mcg/mL Fentanyl Citrate (Preservative Free) Injection172910135M
2K84535 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172910154M
2P61651 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride172930052M
2K91154 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride172930100M
2K82042 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride172970053M
3303NO-K2550 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged172970130M
2T666310 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride172970158M
2R3303-550 mcg/mL Fentanyl Citrate (Preservative Free) Injection172980111M
2K90371 mg/mL Midazolam HCl ( Preservative Free) in 0.9% Sodium Chloride Injection USP172980202M
2K84981 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride173020065M
2K91000.5 mg/mL Midazolam HCl in 0.9% Sodium Chloride173020131M
2T62313 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe173020134M
2K86384 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173020141M
2K82413 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173020185M
2R3306-K550 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged173020228M
2R3333-550 mg/mL Ephedrine Sulfate Injection (Preservative Free)173020233M
2T64552 mg/mL Morphine Sulfate in 0.9% Sodium Chloride173030008M
2P86521 mg/mL Morphine Sulfate in 0.9% Sodium Chloride173030017M
3303NO50 mcg/mL Fentanyl Citrate (Preservative Free) Injection173030024M
2K88692 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173030050M
2K86433 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173030080M
2K77101 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride173030114M
2T68271 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 5% Dextrose173030146M
2T61651 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride173040042M
2T61651 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride173040043M
2K82921 mg/mL Midazolam HCl in 0.9% Sodium Chloride173040069M
2T62701 mg/mL Midazolam HCl in 0.9% Sodium Chloride173040072M
2M85101 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride173040078M
2K81200.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173040265M
2T66565 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride173040283M
2T61651 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride173110038M
2K84682 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173110066M
2K866720 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride173110079M
2T61781 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride173110142M
2K585610 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag173110193M
2T847450 mcg/mL Fentanyl Citrate (Preservative Free) Injection173170055M
3117NO5 mg/mL Labetalol HCI173170127M
2K81791 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride173200084M
2R3417-K51 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride173200212M
2K866920 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride173210054M
2K89370.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride173210060M
3303NO50 mcg/mL Fentanyl Citrate (Preservative Free) Injection173210085M
2T64012 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride173210101M
2R3334-50.5% Ropivacaine HCl Injection (Preservative Free)173210124M

Expanded Press Release

 

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Product Photos

10 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag

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

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

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

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

20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride

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

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

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

1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride

1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride

1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride

1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride

50 mcg/mL Fentanyl Citrate (Preservative Free) Injection

50 mcg/mL Fentanyl Citrate (Preservative Free) Injection

0.5% Ropivacaine HCl Injection (Preservative Free)

1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride

1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride

1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride

3 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe

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

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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