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

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

PR Newswire (paid press release):

LAKE FOREST, Ill., Dec. 27, 2017 /PRNewswire/ — 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.

Lots Affected:

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

Consumers

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

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SOURCE PharMEDium Services, LLC

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