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.
PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance |
| [27-December-2017] |
| LAKE FOREST, Ill., Dec. 27, 2017 /PRNewswire/ -- 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
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2K8880 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790045M
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2K8468 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790055M
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2K8889 2 mcg/mL Fentanyl Citrate and 0.15% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172790091M
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2P8652 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 172790111M
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2P6179 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 172790115M
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2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 172790156M
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2K8124 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172820087M
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3357NO-K25 20 mg/mL Succinylcholine Chloride Injection (Preserved) Kit Check Tagged 172820144M
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2K8490 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910035M
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2K8191 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910106M
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3217NO-K25 0.2 mg/mL Glycopyrrolate 3 mL in 3 mL BD Syringe Kit Check Tagged 172910127M
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2R3303-5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 172910135M
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2K8453 5 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172910154M
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2P6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 172930052M
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2K9115 4 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 172930100M
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2K8204 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 172970053M
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3303NO-K25 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged 172970130M
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2T6663 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 172970158M
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2R3303-5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 172980111M
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2K9037 1 mg/mL Midazolam HCl ( Preservative Free) in 0.9% Sodium Chloride Injection USP 172980202M
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2K8498 1 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 173020065M
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2K9100 0.5 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173020131M
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2T6231 3 mg/mL Adenosine Injection 30 mL in 30 mL BD Syringe 173020134M
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2K8638 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173020141M
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2K8241 3 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173020185M
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2R3306-K5 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection Kit Check Tagged 173020228M
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2R3333-5 50 mg/mL Ephedrine Sulfate Injection (Preservative Free) 173020233M
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2T6455 2 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 173030008M
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2P8652 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride 173030017M
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3303NO 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173030024M
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2K8869 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173030050M
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2K8643 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173030080M
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2K7710 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173030114M
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2T6827 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 5% Dextrose 173030146M
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2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040042M
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2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040043M
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2K8292 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173040069M
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2T6270 1 mg/mL Midazolam HCl in 0.9% Sodium Chloride 173040072M
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2M8510 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173040078M
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2K8120 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173040265M
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2T6656 5 mg/mL Morphine Sulfate (Preservative Free) in 0.9% Sodium Chloride 173040283M
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2T6165 1 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 173110038M
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2K8468 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173110066M
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2K8667 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 173110079M
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2T6178 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173110142M
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2K5856 10 mEq Potassium Chloride in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag 173110193M
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2T8474 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173170055M
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3117NO 5 mg/mL Labetalol HCI 173170127M
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2K8179 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173200084M
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2R3417-K5 1 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173200212M
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2K8669 20 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 173210054M
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2K8937 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 173210060M
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3303NO 50 mcg/mL Fentanyl Citrate (Preservative Free) Injection 173210085M
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2T6401 2 mg/mL Morphine Sulfate (Preservative Free) (Contains Sulfites) in 0.9% Sodium Chloride 173210101M
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2R3334-5 0.5% Ropivacaine HCl Injection (Preservative Free) 173210124M
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Consumers PharMEDium Services, LLC
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